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PF-03715455 in moderate to severe COPD
NCT02366637Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2015
- Primary completion
- May 2015
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- PF-03715455
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 2, randomised, double-blind trial in chronic obstructive pulmonary disease (COPD) comparing Placebo with PF-03715455 (2 arms). Primary endpoint: Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 4. Started Jan 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Orally inhaled placebo twice a day
PF-03715455
680 micrograms BID, Orally inhaled PF-03715455
03
Who it enrols
Patients aged 40-80 with moderate to severe COPD (Stage II-III) and a smoking history of at least 10 pack-years. Excludes patients with recent COPD exacerbations requiring oral steroids or hospitalization.
04
Endpoints
Primary
Change From Baseline in Trough Forced Expiratory Volume in 1 Second
Secondary
Change From Baseline in Sputum Cell Counts
Change From Baseline in Trough FEV1
Change From Baseline in Forced Vital Capacity
Maximum Observed Plasma Concentrations of PF-03715455
Trough Plasma Concentration of PF-03715455
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