A study to assess the safety of selnoflast in participants with chronic obstructive pulmonary disease
| ISRCTN | ISRCTN17672960 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17672960 |
| EudraCT/CTIS number | 2021-000558-25 |
| Secondary identifying numbers | BP43098, CPMS 50074 |
- Submission date
- 26/08/2021
- Registration date
- 08/12/2021
- Last edited
- 04/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Background and study aims
This is a research study (also known as a clinical trial) of a drug called selnoflast. Selnoflast is being developed for the possible treatment of chronic obstructive pulmonary disease (COPD). COPD is the name for a group of lung conditions that cause breathing difficulties.
Who can participate?
Patients aged 35 and 75 years who have had COPD for at least 1 year); please refer to the inclusion criteria
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group will receive selnoflast and those in the other group will receive placebo capsules that look like selnoflast but do not contain active medication. All participants will receive placebo for at least 14 days during the study.
What are the possible benefits and risks of participating?
There is no guarantee that participants will receive any benefits from this study, and taking part in this study may or may not cause their health to improve. Information from this study may help doctors learn more about selnoflast and the treatment of COPD. This information may benefit other patients with COPD or a similar condition in the future. Selnoflast has been tested previously in healthy volunteers. Side effects seen were mild headache and nausea in some patients. The side effects resolved without additional treatment. The following are potential risks that may occur with selnoflast, but they have not been observed so far:
Liver toxicity (deterioration of liver function): some of the healthy volunteers who received selnoflast in a previous study showed mild increase in the laboratory parameters used to evaluate the liver function. If patients have an abnormal blood test of liver function, they will not be included in this study. Liver function will be monitored closely during the study through blood tests.
Infection: selnoflast works by inhibiting a protein complex called the NLRP3 inflammasome, which regulates the immune system. Inhibition of the immune system could result in increased susceptibility to infections. If patients have a known active infection, they will not be included in this study. Participants will be closely monitored for infections to ensure prompt treatment is received.
Impaired response to vaccinations: the NLRP3 inflammasome is activated by many vaccines and it ensures an adequate immune response to vaccination. Therefore, inhibition of the inflammasome may impair the response to vaccination. If participants require a vaccination, these should be completed at least 4 weeks prior to the first dose of study treatment. If participants plan to be vaccinated shortly after completing this study, they should discuss this with the study doctor.
Where is the study run from?
F. Hoffmann-La Roche Ltd (Switzerland)
When is the study starting and how long is it expected to run for?
June 2021 to March 2024
Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)
Who is the main contact?
global-roche-genentech-trials@gene.com
Contact information
Dr Clinical Trials
Public
Public
Grenzacherstrasse 124
Basel
4070
Switzerland
| Phone | +41 (0)888 662 6728 |
|---|---|
| global-roche-genentech-trials@gene.com |
Study information
| Study design | Phase Ib randomized double-blind placebo-controlled parallel-group clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Phase Ib, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety of selnoflast in participants with chronic obstructive pulmonary disease |
| Study hypothesis | The aim is to assess the safety profile of selnoflast compared with that of placebo. |
| Ethics approval(s) | 1. UK: Approval pending, East of Scotland Research Ethics Service (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY, UK; +44 (0)1382 383871; tay.eosres@nhs.scot) 2. Germany: Approval pending, Ethik-Kommission der Landesaerztekammer Hessen (Hanauer Landstraße 152, 60314 Frankfurt am Main, Germany; no telephone number provided; no email provided) 3. USA: Approved 08/07/2021, Advarra (6100 Merriweather Dr., Suite 600, Columbia, MD 21044, USA; +1 (0)410 884 2900, +1 (0)443 283 1522, +1 (0)206 902 3325; rebecca.fisher@advarra.com, andy.basinger@advarra.com) 4. Israel: Approved 17/10/2021, Ethics Helsinki Committee of Barzilai Medical Center (2 Hahistadrout St., Ashkelon, 7830604, Israel; +972 (0)8 6746369, +972 (0)6745550; kerena@bmc.gov.ilmalkam@bmc.gov.il) |
| Condition | Chronic obstructive pulmonary disease |
| Intervention | All participants will be centrally assigned to randomized study treatment using an IxRS system. Randomization will be stratified by smoking status (current/former) to obtain an approximately 1:1 ratio between the two treatment arms within each stratum. Selnoflast: 200 mg by mouth on Days 7, 14, 21, and 28 Placebo: N/A dosage by mouth on Days 7, 14, 21, and 28 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Selnoflast (RO7486967) |
| Primary outcome measure | 1. Incidence and severity of adverse events (AEs) and serious AEs (SAEs) determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) and causal relationship of AEs, incidence of SAEs and AEs leading to treatment discontinuation, recorded throughout the study up to 12 weeks 2. Incidence of abnormal laboratory findings 3. Incidence of abnormal vital signs and electrocardiogram (ECG) parameters Timepoint(s) for 1-3: up to 12 weeks |
| Secondary outcome measures | 1. Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1), measured by spirometry 2. Post-bronchodilator (post-BD) FEV1 measured by spirometry 3. Pre-BD FEV1 percentage of predicted measured by spirometry 4. Post-BD FEV1 percentage of predicted measured by spirometry 5. Pre-BD total lung capacity (TLC) measured by body plethysmography 6. Pre-BD residual volume (RV) measured by body plethysmography 7. Pre-BD functional residual capacity (FRC) measured by body plethysmography 8. RV/TLC ratio measured by body plethysmography 9. Pre-BD forced expiratory flow over the middle one half of the FVC (FEF25-75) measured by spirometry 10. Post-BD FEF25-75 measured by spirometry 11. Pharmacokinetic (PK) parameters of selnoflast in blood by PK population analysis Timepoints for 1-10: Screening (Day-42 to Day -15), Day -14, Day 1, Day 14, Day 28, Day 42, at unscheduled visit, at early termination visit Timepoints for 11: Day 1, Day 7, Day 14, Day 21, Day 28, at unscheduled visit |
| Overall study start date | 04/06/2021 |
| Overall study end date | 22/06/2022 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 106 |
| Total final enrolment | 1 |
| Participant inclusion criteria | Current inclusion criteria as of 14/06/2022: 1. Between 35 and 75 years of age (inclusive) 2. Participants with >=12-month diagnosis of COPD 3. Radiologic evidence of air trapping at screening based on chest HRCT conducted per imaging acquisition protocol and reviewed by the imaging central reader 4. Extent of emphysema on HRCT at screening is < 25% 5. GOLD 2020 Grade 2/3, characterized by a post-bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <= 0.70 and a post-bronchodilator FEV1 of >=30% and =< 79% of predicted at screening and with an exacerbation history >= 2 or >= 1 leading to hospitalization within the last 12 months 6. COPD assessment test (CAT) score >=10 and with a clinical diagnosis of chronic bronchitis, characterized by cough and sputum production on most days for a minimum of 3 months during the last year 7. Participant must have a body mass index (BMI) between 18 and 35 kg/m² 8. Abnormal laboratory values high sensitivity CRP (hs-CRP) >= 3 mg/L at screening and absolute neutrophil count >= 6.0 x 109/L in whole blood at screening 9. Vital signs (body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate) will be assessed in the sitting position after the subject has rested for at least 3 minutes 10. Unchanged standard regimen of care for >= 4 weeks prior to screening 11. Ex-smokers with at least a 10-pack year smoking history or current smokers with at least a 10 pack-year smoking history who smoke =< 1 pack-year on average in the last 3 months as reported at screening 12. Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines 13. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: women of non-childbearing potential or women of childbearing potential who agree to remain abstinent or use at least acceptable contraceptive methods during the treatment period and for at least 14 days after the final dose of selnoflast /placebo 14. Male participants: No contraception required for male participants Previous inclusion criteria: 1. Between 35 and 75 years of age (inclusive) 2. Patients with >=12-month diagnosis of COPD 3. Radiologic evidence of air trapping at screening based on chest HRCT conducted per imaging acquisition protocol and reviewed by the imaging central reader 4. Extent of emphysema on HRCT at baseline is < 25% 5. GOLD 2020 Grade 2/3, characterized by a post-bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio <= 0.70 and a post-bronchodilator FEV1 of >= 30% and =< 79% of predicted at screening and with an exacerbation history >= 2 or >= 1 leading to hospitalization within the last 12 months 6. COPD assessment test (CAT) score >=10 and with a clinical diagnosis of chronic bronchitis, characterized by cough and sputum production on most days for a minimum of 3 months during the last year 7. Participant must have a body mass index (BMI) between 18 and 35 kg/m² 8. Abnormal laboratory values 9. Vital signs (body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate) will be assessed in the sitting position after the subject has rested for at least 3 minutes 10. Unchanged standard regimen of care for >= 4 weeks prior to screening 11. Ex-smokers with at least a 10-pack year smoking history or current smokers with at least a 10 pack-year smoking history who smoke =< 1 pack-year on average in the last 3 months as reported at screening 12. Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines 13. Female participants: a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: women of non-childbearing potential or women of childbearing potential who agree to remain abstinent or use at least acceptable contraceptive methods during the treatment period and for at least 14 days after the final dose of RO7486967/placebo 14. Male participants: No contraception required for male participants |
| Participant exclusion criteria | Current exclusion criteria as of 14/06/2022: 1. Any condition or disease detected during the medical interview/physical examination that would render the patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study 2. Known active or uncontrolled bacterial, viral, fungal, mycobacterial, or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with SARS-CoV-2 within 2 weeks prior to screening 3. Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within 6 weeks prior to Day 1 4. Diagnosis of severe bronchiectasis in chart or history 5. Participants with another concomitant pulmonary disease, including but not exclusive of, interstitial pulmonary fibrosis, sarcoidosis, or other granulomatous or infectious process 6. Participants treated for active asthma within 2 years prior to the screening visit 7. Any COPD exacerbation or upper or lower respiratory tract infection requiring antibiotics, oral steroids, or hospitalization within 2 weeks prior to screening, during the screening period, or during the run-in period 8. Participants requiring long-term oxygen therapy for daytime hypoxemia 9. Participants with a diagnosis of alpha-1 antitrypsin deficiency 10. History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 5 years 11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study 12. History of clinically significant ECG abnormalities, or ECG abnormalities at screening 13. Known family history or known presence of long QT syndrome 14. Participant with a history of acute coronary syndrome in 3 months prior to the screening visit 15. Participants with a history of coronary artery bypass surgery or other major vascular surgery within 6 months prior to the screening visit 16. Evidence of urinary obstruction or difficulty in voiding 17. History of any clinically significant hepatic disease or cirrhosis 18. Significant illness not resolved within 2 weeks prior to screening 19. Use of systemic steroids, ICS, theophylline, and phosphodiesterase 4 (PDE4) inhibitors within 4 weeks of screening 20. Vaccines within 4 weeks prior to the first dose 21. Current treatment with medications that are well known to prolong the QT interval 22. Donation or loss of 450 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation 23. Plasma donation > 150 mL within 7 days prior to first dosing 24. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations 25. History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients 26. QTcF > 450 ms in male participants and > 470 ms in female participants 27. Liver function test abnormalities at screening. Re-testing during the screening period is possible once. This laboratory assessment may be repeated once during the screening period, if necessary 28. Anemia (hemoglobin levels >10.0 g/dl at screening). This laboratory assessment may be repeated once during the screening period, if necessary 29. Clinical evidence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) at screening. This laboratory assessment may be repeated once during the screening period, if necessary 30. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result 31. Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HBcAb), or positive hepatitis C by PCR test result at screening or within 3 months prior to starting study treatment 32. History of tuberculosis or a positive Quantiferon Gold test 33. Participants with a known history of noncompliance to medication, or who are unable or unwilling to complete an electronic patient diary (medication adherence platform), or who are unable to demonstrate good medication compliance during the run-in period 34. Inability to comply with all study requirements and demonstrate good medication compliance during the treatment run-in period 35. Participants with any medical or psychological condition that renders the patient unable to understand the nature, scope, and possible consequences of the study 36. Participants with a history of being unable to swallow size 0 capsules 37. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening 38. Clinically significant history of psychiatric disorders that preclude understanding or compliance with the protocol 39. Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction Previous exclusion criteria: 1. Any condition or disease detected during the medical interview/physical examination that would render the patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study 2. Known active or uncontrolled bacterial, viral, fungal, mycobacterial, or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with SARS-CoV-2 within 2 weeks prior to screening 3. Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within 6 weeks prior to Day 1 4. Diagnosis of severe bronchiectasis in chart or history 5. Patients with another concomitant pulmonary disease, including but not exclusive of, interstitial pulmonary fibrosis, sarcoidosis, or other granulomatous or infectious process 6. Patients treated for active asthma within 2 years prior to the screening visit 7. Any COPD exacerbation or upper or lower respiratory tract infection requiring antibiotics, oral steroids, or hospitalization within 2 weeks prior to screening, during the screening period, or during the run-in period 8. Patients requiring long-term oxygen therapy for daytime hypoxemia 9. Patients with a diagnosis of alpha-1 antitrypsin deficiency 10. History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin) within the past 5 years 11. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study 12. History of clinically significant ECG abnormalities, or ECG abnormalities at screening or baseline 13. Known family history or known presence of long QT syndrome 14. Patients with a history of acute coronary syndrome in 3 months prior to the screening visit 15. Patients with a history of coronary artery bypass surgery or other major vascular surgery within 6 months prior to the screening visit 16. Evidence of urinary obstruction or difficulty in voiding 17. History of any clinically significant hepatic disease or cirrhosis 18. Significant illness not resolved within 2 weeks prior to screening 19. Use of systemic steroids, ICS, theophylline, and phosphodiesterase 4 (PDE4) inhibitors within 4 weeks of screening 20. Vaccines within 4 weeks prior to the first dose 21. Current treatment with medications that are well known to prolong the QT interval 22. Donation or loss of 450 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation 23. Plasma donation > 150 mL within 7 days prior to first dosing 24. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations 25. History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients 26. QTcF > 450 ms in male participants and > 470 ms in female participants demonstrated by at least two ECGs >30 minutes apart 27. Liver function test abnormalities at screening. Re-testing during the screening period is possible once. 28. Anemia (hemoglobin levels >10.0 g/dl at screening) 29. Clinical evidence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria) at screening 30. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result 31. Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HBcAb), or positive hepatitis C by PCR test result at screening or within 3 months prior to starting study treatment 32. History of tuberculosis or a positive Quantiferon Gold test 33. Patients with a known history of noncompliance to medication, or who are unable or unwilling to complete an electronic patient diary (medication adherence platform), or who are unable to demonstrate good medication compliance during the run-in period 34. Inability to comply with all study requirements and demonstrate good medication compliance during the treatment run-in period 35. Patients with any medical or psychological condition that renders the patient unable to understand the nature, scope, and possible consequences of the study 36. Patients with a history of being unable to swallow size 0 capsules 37. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening 38. Clinically significant history of psychiatric disorders that preclude understanding or compliance with the protocol 39. Recent (within the last 3 years) and/or recurrent history of autonomic dysfunction |
| Recruitment start date | 25/04/2022 |
| Recruitment end date | 25/04/2022 |
Locations
Countries of recruitment
- Germany
- Israel
- Netherlands
- Spain
- United Kingdom
- United States of America
Study participating centres
IKF Pneumologie
Frankfurt am Main
60596
Germany
60596
Germany
Hadassah Medical Center - PPDS
PO Box 12000
Jerusalem
91120
Israel
Jerusalem
91120
Israel
Barzilai Medical Center
2 Hahistadrout Street
Ashkelon
7827800
Israel
Ashkelon
7827800
Israel
IKF Pneumologie
Schaumainkai 101-103
Frankfurt am Main
Hessen
60596
Germany
Frankfurt am Main
Hessen
60596
Germany
Lungenfachklinik Immenhausen
Robert-Koch-Str. 3
Immenhausen
Hessen
34376
Germany
Immenhausen
Hessen
34376
Germany
Edith Wolfson Medical Center
Ha-Lokhamim St 62, Holon
Tel-Aviv
58100
Israel
Tel-Aviv
58100
Israel
Shaare Zedek Medical Center
12 Shmuel Biet Street
Jerusalem
91031
Israel
Jerusalem
91031
Israel
IFG Institut für Gesundheitsförderung GmbH
Otto-Nuschke-Str. 2
Rüdersdorf
Brandenburg
15562
Germany
Rüdersdorf
Brandenburg
15562
Germany
Queen Anne Street Medical Centre
18-22 Queen Anne Street
London
W1G 8HU
United Kingdom
London
W1G 8HU
United Kingdom
Kaplan Medical Center
Tremona Road
Mailpoint 24
Rehovot
76100
Israel
Mailpoint 24
Rehovot
76100
Israel
Sheba Medical Center PPDS
2 Sheba Road
Tel Hashomer
52621
Israel
Tel Hashomer
52621
Israel
Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
Röntgenstr. 1 Heidelberg
Baden-Württemberg
69126
Germany
Baden-Württemberg
69126
Germany
IKF Pneumologie Mainz
Haifa Allee 24
Mainz
55128
Germany
Mainz
55128
Germany
Rabin Medical Center - PPDS
39, Jabotinski Street
Petah Tiqva
49100
Israel
Petah Tiqva
49100
Israel
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
3652 Eureka Way
Redding
96001-0172
United States of America
Redding
96001-0172
United States of America
IMIC Inc.
18320 Franjo Rd
Palmetto Bay, FL
33157
United States of America
Palmetto Bay, FL
33157
United States of America
Southampton General Hospital
Tremona Road
Mailpoint 24
Southampton
S016 6YD
United Kingdom
Mailpoint 24
Southampton
S016 6YD
United Kingdom
Legacy Clinical Solutions: Tandem Clinical Research, LLC
Clinedge - PPDS
1111 Medical Center Blvd
Marrero
70072-3151
United States of America
1111 Medical Center Blvd
Marrero
70072-3151
United States of America
Atria Clinical Research - Clinedge - PPDS
11321 I-30 Suite 308
Little Rock
72209
United States of America
Little Rock
72209
United States of America
Ninewells Hospital - PPDS
Ninewells Avenue
Dundee
DD1 9SY
United Kingdom
Dundee
DD1 9SY
United Kingdom
Research Center for Medical Studies RCMS
Hohenzollerndamm 2
Berlin
10717
Germany
Berlin
10717
Germany
Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V
Gießen
35392
Germany
35392
Germany
KLB Gesundheitsforschung Lubeck GmbH
Lübeck
23552
Germany
23552
Germany
Praxis Dr med Claus Keller
Usinger Str. 5
Frankfurt
60389
Germany
Frankfurt
60389
Germany
RoMed Klinikum Rosenheim
Rosenheim
83022
Germany
83022
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik
Mainz
55131
Germany
55131
Germany
Soroka University Medical Centre
3652 Eureka Way
Be'er Sheva
84417
Israel
Be'er Sheva
84417
Israel
Universitair Medisch Centrum Groningen
GZ Groningen
9713
Netherlands
9713
Netherlands
Albert Schweitzer Ziekenhuis; Afdeling Longziekten
AK Dordrecht
3300
Netherlands
3300
Netherlands
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcón
Madrid
28223
Spain
Madrid
28223
Spain
Hospital Universitario Virgen de Las Nieves
Granada
18012
Spain
18012
Spain
NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Royal Liverpool University Hospital
Liverpool
L7 8XP
United Kingdom
L7 8XP
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
B15 2GW
United Kingdom
B15 2GW
United Kingdom
Houston Pulmonary, Sleep & Allergy Associates
Cypress, TX
77429-4696
United States of America
77429-4696
United States of America
Clinical Site Partners - Leesburg
Suite 101 - HyperCore - PPDS
Leesburg, FL
34748-5077
United States of America
Leesburg, FL
34748-5077
United States of America
Clinical Research Associates of Central Pa, Llc
Altoona, PA
16602
United States of America
16602
United States of America
Clinical Research of Gastonia
Gastonia, NC
28054
United States of America
28054
United States of America
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, CA
90502
United States of America
90502
United States of America
Clinical Research of Rock Hill
Rock Hill, SC
29732
United States of America
29732
United States of America
U Health Ball Memorial Physicians Pulmonary & Critical Care Medicine
Muncie, IN
47303
United States of America
47303
United States of America
Velocity Clinical Research - Union - ERN - PPDS
Union, SC
29379
United States of America
29379
United States of America
Indiana University School of Medicine - Indianapolis
Indianapolis, IN
46202
United States of America
46202
United States of America
Hannibal Clinic
Hannibal, MO
63401
United States of America
63401
United States of America
North Florida Foundation For Research and Education, Inc.
Florida
32608
United States of America
32608
United States of America
Temple Lung Center, Temple University of the Commonwealth System of Higher Education
Philadelphia, PA
19140
United States of America
19140
United States of America
University of Cincinnati / University of Cincinnati College of Medicine
Cincinnati, OH
45267
United States of America
45267
United States of America
Sponsor information
Roche (Switzerland)
Industry
Industry
Grenzacherstrasse 124
Basel
4070
Switzerland
| Phone | +41 (0)888 662 6728 |
|---|---|
| global-roche-genentech-trials@gene.com | |
| Website | global-roche-genentech-trials@gene.com |
"ROR" |
https://ror.org/00by1q217 |
Funders
Funder type
Industry
F. Hoffmann-La Roche
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Hoffman-La Roche, F. Hoffmann-La Roche Ltd.
- Location
- Switzerland
Results and Publications
| Intention to publish date | 29/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to participant-level data not being a regulatory requirement for Phase I studies. |
Editorial Notes
04/12/2023: Study website added.
14/11/2022: The following changes were made to the trial record:
1. The overall end date was changed from 29/03/2024 to 22/06/2022.
2. The recruitment end date was changed from 31/01/2024 to 25/04/2022.
3. The plain English summary was updated to reflect these changes.
4. The study was stopped.
16/06/2022: Internal review.
14/06/2022: The following changes were made to the trial record:
1. RO7486967 was changed to selnoflast throughout the trial record.
2. Ethics approval details added.
3. The inclusion and exclusion criteria were updated.
4. The recruitment start date was changed from 06/10/2021 to 25/04/2022.
5. The recruitment end date was changed from 05/04/2022 to 31/01/2024.
6. The overall trial end date was changed from 31/05/2022 to 29/03/2024.
7. The intention to publish date was changed from 31/05/2023 to 29/03/2025.
8. Universitaetsklinikum Giessen und Marburg GmbH; Medizinische Klinik IV und V, KLB Gesundheitsforschung Lubeck GmbH, Praxis Dr med Claus Keller, RoMed Klinikum Rosenheim, Universitätsmedizin der Johannes Gutenberg-Universität Mainz; II. Medizinische Klinik, Soroka University Medical Centre, Universitair Medisch Centrum Groningen, Albert Schweitzer Ziekenhuis; Afdeling Longziekten, Hospital Universitario Quironsalud Madrid, Hospital Universitario Virgen de Las Nieves, NIHR Leicester-Loughborough Diet, Lifestyle and Physical Activity Biomedical Research Unit, Royal Liverpool University Hospital, University Hospitals Birmingham NHS Foundation Trust, Houston Pulmonary, Sleep & Allergy Associates, Clinical Site Partners - Leesburg, Clinical Research Associates of Central Pa, Llc, Clinical Research of Gastonia, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Clinical Research of Rock Hill, IU Health Ball Memorial Physicians Pulmonary & Critical Care Medicine, Velocity Clinical Research - Union - ERN - PPDS, Indiana University School of Medicine - Indianapolis, Hannibal Clinic, North Florida Foundation For Research and Education, Inc., Temple Lung Center, Temple University of the Commonwealth System of Higher Education, University of Cincinnati / University of Cincinnati College of Medicine were added as trial participating centres.
11/01/2022: The CPMS number was added to the protocol/serial no. field.
02/09/2021: Trial's existence confirmed by the US FDA.
