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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274014
First received: January 9, 2006
Last updated: October 31, 2013
Last verified: October 2013

January 9, 2006
October 31, 2013
October 2000
October 2003   (final data collection date for primary outcome measure)
morning peak expiratory flow rate (PEFR) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
The primary endpoint was the morning peak expiratory flow rate (PEFR).
Complete list of historical versions of study NCT00274014 on ClinicalTrials.gov Archive Site
  • incidence, severity and duration of exacerbations [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of patients with one or more exacerbation [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • rate of PEFR drops [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of lost working days [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • number of days of hospitalisation [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • use of rescue medications, type and duration [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • bacterial and viral characterisation of severe exacerbations [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • plethysmography (RV, TLC) (optional) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
  • Adverse events, physical examination [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
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.

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.

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 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.

Comparison(s):

Tiotropium 18 mcg once daily vs Placebo

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
October 2003
October 2003   (final data collection date for primary outcome measure)
  • 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.
Both
41 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00274014
205.214
Not Provided
Not Provided
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.
Boehringer Ingelheim
October 2013

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