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
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • morning peak expiratory flow rate (PEFR) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: October 2000
Estimated Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
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 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

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274014

  Show 55 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI France S.A.S.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274014     History of Changes
Other Study ID Numbers: 205.214
Study First Received: January 9, 2006
Last Updated: October 31, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014