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OpenTrials
Completed

NCT Number: NCT00274521

Tiotropium (Spiriva) Rehabilitation Study

The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.

Exclusion criteria

Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.

Treatment and study plan

Tiotropium

Drug

Primary outcomes

  1. The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity

    Time frame: week 13

Secondary outcomes

  1. Individual FEV1 measurement

    Time frame: week 4, 13, 25

  2. Individual FVC measurement

    Time frame: week 4, 13, 25

  3. St. George.s Hospital Respiratory Questionnaire (SGRQ)

    Time frame: week 4, 13, 25

  4. Transition dyspnea index

    Time frame: week 4, 13, 25

  5. COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)

    Time frame: week 4, 13, 25

  6. Modified Borg scale

    Time frame: week 4, 13, 25

  7. Amount of albuterol therapy used during the treatment period

    Time frame: 25 weeks

  8. Number and length of exacerbations of COPD

    Time frame: 25 weeks

  9. Physician's global evaluation

    Time frame: week 4, 13, 25

  10. Patient peak flow rates twice daily

    Time frame: 25 weeks

  11. Patient activity measurement

    Time frame: week 9, 13, 17, 21, 25

  12. Change in submaximal exercise tolerance during constant work rate exercise

    Time frame: week 25

  13. Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.

    Time frame: week 13

  14. Occurrence of adverse events

    Time frame: 25 weeks

  15. Pulse rate and blood pressure in conjunction with spirometry

    Time frame: 25 weeks

  16. Changes in the physical examination from baseline and at the conclusion of patient participation in the trial

    Time frame: 25 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.

Important dates

Study start
2001
Primary completion
2003
First posted
Jan 11, 2006
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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