Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00274014

First received: January 9, 2006

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

May 11, 2012

Start Date ^ICMJE

October 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

The primary endpoint was the morning peak expiratory flow rate (PEFR).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00274014 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary efficacy endpoints were: incidence, severity and duration of exacerbations number of patients with one or more exacerbation rate of PEFR drops number of lost working days number of days of hospitalisation use of rescue medication, etc

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

Official Title ^ICMJE

Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.

Brief Summary

The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

Detailed Description

This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.

Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).

PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.

Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.

Study Hypothesis:

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

Comparison(s):

Tiotropium 18 mcg once daily vs Placebo

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Drug: Tiotropium

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1000

Completion Date

October 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:
- Stable moderate to severe airway obstruction
- Baseline 30 % < FEV1 < 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
- Baseline FEV1/SVC< 70 %.
Smoking history > 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
One pack of cigarettes per day for one year.
History of exacerbation in the past year.

Gender

Both

Ages

41 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00274014

Other Study ID Numbers ^ICMJE

205.214

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

BI France S.A.S.

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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