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Acute Effect of Aclidinium on Hyperinflation in Severe COPD
NCT02181023Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- Sep 2014
- Countries
- 1
- Sponsor
- University of Milan
- Modality
- Small Molecules
- Drugs
- aclidinium
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 4, randomised, double-blind trial of aclidinium in chronic obstructive pulmonary disease (COPD) (2 arms), sponsored by University of Milan. Primary endpoints: Residual Volume Variation from baseline at 180 months and Functional Residual Capacity variation from baseline at 180 months. Started Jun 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Aclidinium then Glycopyrronium
Sequence: Aclidinium Bromide first, then Glycopyrronium Bromide
Glycopyrronium then Aclidinium
Sequence: Glycopyrronium Bromide first, then Aclidinium Bromide
03
Endpoints
Primary
Residual Volume Variation from baseline
Functional Residual Capacity variation from baseline
Secondary
Phase III slope variation from baseline
Visual Analogical Scale (VAS) for Dyspnoea at rest variation from baseline
Oxygen and Carbon Dioxide variation from baseline
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