Phase 2
Completed N=75
Efficacy and Safety Study in Subjects With Asthma
Source: ClinicalTrials.gov NCT00980200 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period — 0.059; 0.153; 0.198; 0.161 Liters — p=<0.001
Summary
The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough (Pre-bronchodilator and Pre-dose) FEV1 on Day 7 of the Treatment Period |
0.059; 0.153; 0.198; 0.161; 0.184 | <0.001 sig |
| SECONDARY Change From Baseline in Weighted Mean 24-hour FEV1 on Day 7 of the Treatment Period |
0.028; 0.181; 0.194; 0.196; 0.213 | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient
- ≥18 years of age at Visit 1
- Male or Eligible Female
- Diagnosis of asthma at least 12 weeks prior to Visit 1
- Disease reversibility
- Current anti-asthma therapy
- Appropriately signed and dated informed consent has been obtained
- Able to comply with all the study requirements
Exclusion Criteria
- History of Life-Threatening Asthma
- No use of systemic corticosteroids for any indication within 8 weeks prior to Visit
- No concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation
- Drug Allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate
- History of severe milk protein allergy
- Non-compliance with study medication and other study-related requirements
- No use of inhaled tobacco products within the past three months or historical use of 10 pack years or more
- Administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol
Data sourced from ClinicalTrials.gov (NCT00980200). 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. Informational only — not medical advice.