A Phase 2 interventional study of Placebo and R940343 1mg in Asthma, sponsored by Rigel Pharmaceuticals. Completed at 59 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-09-29.
Sponsored by Rigel Pharmaceuticals · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after an initial screening evaluation and a single-blind, run-in period will be randomized to receive either R343 or placebo.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 301 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Rigel Pharmaceuticals is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
R343 2mg, 2 puffs bid
Drug: R940343 2mg
Drug: Placebo
R343 1mg, 1 puff bid
Drug: R940343 1mg
1 puff bid or 2 puffs bid
R343 1mg, 1 puff bid
Also known as: R343
R343 2mg, 2 puffs bid
Also known as: R343
Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Time frame: Baseline and Week 8
| Milestone | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid |
|---|---|---|---|
| Started | 101 | 100 | 100 |
| Completed | 94 | 91 | 96 |
| Not completed | 7 | 9 | 4 |
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
| percentage of change | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid |
|---|---|---|---|
| Change in FEV1 | -0.40 ± 8.56 | 0.69 ± 9.31 | -0.59 ± 8.75 |
Collected over The adverse event reporting period begins with the first dose of study drug and ends with the final study follow-up visit (week 9).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| R940343 2mg, 2 Puffs Bid | — | 0/101 (0%) | 36/101 (35.6%) |
| Placebo | — | 0/100 (0%) | 48/100 (48%) |
| R940343 1mg, 1 Puff Bid | — | 0/100 (0%) | 26/100 (26%) |
| Event | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid |
|---|---|---|---|
| Infections and infestationsInfections and infestations | 20/101 | 26/100 | 9/100 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 4/101 | 9/100 | 8/100 |
| InvestigationsInvestigations | 3/101 | 3/100 | 1/100 |
| Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 0/101 | 3/100 | 1/100 |
| Skin and Subcutaneous Tissue DisordersSkin and subcutaneous tissue disorders | 2/101 | 3/100 | 0/100 |
| Cardiac DisordersCardiac disorders | 0/101 | 2/100 | 0/100 |
| Gastrointestinal DisordersGastrointestinal disorders | 1/101 | 1/100 | 2/100 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 2/101 | 1/100 | 2/100 |
| Eye DisordersEye disorders | 1/101 | 1/100 | 1/100 |
| BLOOD AND LYMPHATIC SYSTEM DISORDERSBlood and lymphatic system disorders | 0/101 | 1/100 | 0/100 |
For the purpose of analysis, participants randomized to the two different dosage levels of the placebo were considered a single Arm/Group.
| Age, Continuous(years) | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid | Total |
|---|---|---|---|---|
| Mean | 39.5 ± 13.5 | 38.3 ± 12.6 | 39.3 ± 12.8 | 39.1 ± 13 |
| Sex: Female, Male(Participants) | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid | Total |
|---|---|---|---|---|
| Female | 51 | 58 | 55 | 164 |
| Male | 50 | 42 | 45 | 137 |
Plan to share: No
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Rigel Pharmaceuticals