Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium; Placebo
Intervention description: double blind randomized crossover; inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 126.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.

        Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a
        significant disease including COPD.