Phase 2
N=15
PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00723021 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) — 2.624; 2.626; 2.585; 2.579 L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04191834 (Drug); zileuton (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
2.624; 2.626; 2.585; 2.579; 2.609; 0.122 | — |
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
2.624; 2.626; 2.585; 2.579; 2.609; 0.122 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
3.852; 3.891; 3.720; 3.792; 3.821; 0.162 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) |
3.852; 3.891; 3.720; 3.792; 3.821; 0.162 | — |
| SECONDARY Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) |
1.951; 1.901; 1.807; 1.915; 1.959; 0.146 | — |
| SECONDARY Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) |
1.951; 1.901; 1.807; 1.915; 1.959; 0.146 | — |
Summary
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
Eligibility Criteria
Inclusion Criteria
- Persistent mild/moderate asthma for at least 6 months.
- Reduced lung function
- Reversible airway obstruction
Exclusion Criteria
- Pregnant/nursing females.
- Liver function tests greater than upper limit of normal (ULN)
Data sourced from ClinicalTrials.gov (NCT00723021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.