Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive; Asthma

• Registration Number: NCT00152984
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)	after 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	12 weeks
AUC0-6hFVC defined in the same way as for FEV1.	Day 1, week 4
Trough FVC defined in the same way as for FEV1.	Day 1, week 4
Peak FVC defined in the same way as for FEV1	Day 1, week 4
Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement).	12 weeks
Weekly average number of puffs of rescue medication used	12 weeks
Occurrence of adverse events	12 weeks
Peak expiratory flow rate (PEFR)	12 weeks
AUC0-6hFEV1	after first dose on Day 1 and after 4 weeks of treatment
Change in trough FEV1 (i.e. trough response) from baseline.	after 4 and 12 weeks of treatment
Change in peak FEV1 from baseline (=peak response) after first dose	after 4 and 12 weeks of treatment
Change from baseline in Physical examination	12 weeks
Use of rescue medication	12 weeks
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry	12 weeks

Trial Locations

Locations (43)

CHU Sart Tilman; 🇧🇪 Angleur, Belgium

A.Z. VUB; 🇧🇪 Brussel, Belgium

Boehringer Ingelheim Investigational Site; 🇿🇦 Somerset West, South Africa

St. Elisabethziekenhuis; 🇧🇪 Herentals, Belgium

Clinique Reine Astrid; 🇧🇪 Malmedy, Belgium

Sint-Elisabethziekenhuis; 🇧🇪 Turnhout, Belgium

VGH Research Pavillion; 🇨🇦 Vancouver, British Columbia, Canada

BG 034, Room C2027; 🇨🇦 Winnipeg, Manitoba, Canada

Department of Medicine, Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

Respiratory Research Lab; 🇨🇦 Toronto, Ontario, Canada

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