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Spiriva HandiHaler in COPD (MATHS)
NCT01644734Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Mar 2013
- Countries
- 1
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- tiotropium
- Conditions
- chronic obstructive pulmonary disease (COPD)
01
Overview
Phase 4, open-label, single-arm trial of tiotropium in chronic obstructive pulmonary disease (COPD), sponsored by Boehringer Ingelheim. Primary endpoint: Number of Patients Maintaining or Improving Their Health Status at 3 months. Started Nov 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Spiriva HandiHaler
03
Who it enrols
Ambulatory outpatients with COPD (GOLD 2010) recently started on Spiriva HandiHaler maintenance therapy (within 4 weeks) after at least 3 months of short-acting bronchodilator use.
04
Endpoints
Primary
Number of Patients Maintaining or Improving Their Health Status
Secondary
Change in the Total COPD Assessment Test Score
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