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Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

NCT ID: NCT01072396

Last Updated: 2013-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-11-30

Brief Summary

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Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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18 mcg tiotropium

Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

double blind randomized crossover

Placebo

Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

inhalation powder capsule identical to those containing tiotropium bromide inhalation powder

Control

Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tiotropium

double blind randomized crossover

Intervention Type DRUG

Placebo

inhalation powder capsule identical to those containing tiotropium bromide inhalation powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For COPD subjects: Male or female, age of 40 years or older, smoking history \>10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio \<70%., FEV1 \>/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion Criteria

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.440.1006 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

205.440.1015 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

205.440.1002 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Site Status

205.440.1018 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Site Status

205.440.1008 Boehringer Ingelheim Investigational Site

Springfield, Illinois, United States

Site Status

205.440.1017 Boehringer Ingelheim Investigational Site

Muncie, Indiana, United States

Site Status

205.440.1020 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

205.440.1011 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Site Status

205.440.1019 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

205.440.1013 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

205.440.1007 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

205.440.2003 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Site Status

205.440.2001 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

205.440.2004 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

205.440.2002 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8.

Reference Type DERIVED
PMID: 26775292 (View on PubMed)

Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.

Reference Type DERIVED
PMID: 25906326 (View on PubMed)

Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC.

Reference Type DERIVED
PMID: 25289942 (View on PubMed)

O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014.

Reference Type DERIVED
PMID: 24788342 (View on PubMed)

Other Identifiers

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205.440

Identifier Type: -

Identifier Source: org_study_id