Asthma
Conditions
Brief summary
The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in the treatment of mild to moderate asthma.
Detailed description
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.
Interventions
DRUGPlacebo
1 puff bid or 2 puffs bid
DRUGR940343 1mg
R343 1mg, 1 puff bid
DRUGR940343 2mg
R343 2mg, 2 puffs bid
Sponsors
Rigel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical history of asthma * Ability to perform spirometry
Exclusion criteria
* Chronic obstructive pulmonary disease or bronchiectasis * Upper or lower respiratory infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1 | Baseline and Week 8 | Change from baseline in pre-BD FEV1 (% predicted) at Week 8. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| R940343 2mg, 2 Puffs Bid R343 2mg, 2 puffs bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid | 101 |
| Placebo Placebo: 1, 1 puff bid or 2, 2 puffs bid | 100 |
| R940343 1mg, 1 Puff Bid R343 1mg, 1 puff bid
R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid | 100 |
| Total | 301 |
Baseline characteristics
| Characteristic | Total | R940343 2mg, 2 Puffs Bid | Placebo | R940343 1mg, 1 Puff Bid |
|---|---|---|---|---|
| Age, Continuous | 39.1 years STANDARD_DEVIATION 13 | 39.5 years STANDARD_DEVIATION 13.5 | 38.3 years STANDARD_DEVIATION 12.6 | 39.3 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 164 Participants | 51 Participants | 58 Participants | 55 Participants |
| Sex: Female, Male Male | 137 Participants | 50 Participants | 42 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 101 | 48 / 100 | 26 / 100 |
| serious Total, serious adverse events | 0 / 101 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Change in FEV1
Change from baseline in pre-BD FEV1 (% predicted) at Week 8.
Time frame: Baseline and Week 8
Population: All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| R940343 2mg, 2 Puffs Bid | Change in FEV1 | -0.40 percentage of change | Standard Deviation 8.56 |
| Placebo | Change in FEV1 | 0.69 percentage of change | Standard Deviation 9.31 |
| R940343 1mg, 1 Puff Bid | Change in FEV1 | -0.59 percentage of change | Standard Deviation 8.75 |