Effect of Tiotropium Inhalation Capsules on Exercise Tolerance, Daily Activity and Dyspnoea in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 3 Weeks of Pulmonary Rehabilitation

NCT02172508 | Terminated Phase 4

• 1 other identifier: 205.289
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study is to investigate the effect of the combined therapy 18 μg tiotropium q.d. plus pulmonary rehabilitation versus placebo plus pulmonary rehabilitation on 6-minute walking distance (6MWD) after 7 weeks of treatment in patients with moderate to severe COPD. The secondary objective of the study includes assessments of the effects of the combined therapy 18 μg Tiotropium q.d. plus rehabilitation versus placebo plus rehabilitation on dyspnoea, constant work rate exercise endurance, daily activity and lung volumes. The third objective of the study is to investigate the correlation between the results of the 6-minute walking test (6MWT), the constant work rate exercise test (CWR) and daily activity.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 6 Minute Walking Distance (6MWD)

  Baseline, day 51

Secondary Outcomes (23)

• Dyspnoea at the end of the 6MWT determined by the Modified Borg Scale (Dyspnoea Borg 6MWT),

  Up to day 51

• Endurance time during a constant work rate exercise test (CWR)

  Up to day 51

• Forced expiratory volume in one second (FEV1)

  Up to day 51

• Forced vital capacity (FVC)

  Up to day 51

• Slow vital capacity (SVC)

  Up to day 51

Study Arms (2)

Tiotropium

EXPERIMENTAL

Drug: Tiotropium Inhalation Capsule

Placebo

PLACEBO COMPARATOR

Drug: Placebo Lactose Capsule

Interventions

Tiotropium Inhalation Capsule DRUG

Tiotropium

Placebo Lactose Capsule DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an Informed Consent Form consistent with ICH-GCP guidelines prior to participation in the trial, which might include pre-study washout of their usual pulmonary medications and restrictions.
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• Patients must have relatively stable airway obstruction with an FEV1 ≤ 65% of predicted normal and FEV1 ≤ 70% of FVC on visit 1 and 3.
• Patients must show TGV ≥ 120% of predicted normal
• Male or female patients ≥ 40 but ≤ 75 years old
• Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
• Patients must be able to perform all study related tests including the exercise tests, acceptable pulmonary function tests and must be able to maintain records during the study period as required in the protocol.
• Patients must be able to inhale medication from the HandiHaler® and from a metered dose inhaler.
• Patients must be already eligible for participation in a pulmonary rehabilitation program as per the investigator's usual criteria.

You may not qualify if:

• Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which, in the opinion of the investigator, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
• All patients with an serum glutamic-oxaloacetic transaminase (SGOT) \> 80 IU/L, serum glutamic-pyruvic transaminase (SGPT) \> 80 IU/L, bilirubin \> 2.0 mg/dL or creatinine \> 2.0 mg/dL will be excluded regardless of clinical condition.
• Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count \> 600/mm3. A repeat eosinophil count will not be conducted in these patients.
• Patients with a recent history (i.e., six months or less) of myocardial infarction.
• Patients with unstable or life-threatening cardiac arrhythmias, including any patient with a newly diagnosed, clinically relevant arrhythmia on the ECG performed on visit 1. Patients with arrhythmias requiring an intervention (i.e. hospitalization, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year should also be excluded from the study.
• Patients who have been hospitalized for heart failure during the past three years.
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed.
• Patients with a history of cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
• Patients with any respiratory infection in the 4 weeks prior to the screening visit and recovery within 6 weeks prior to visit 3 should be randomised 6 weeks following recovery from the infection or exacerbation.
• Patients who are currently in a pulmonary or cardiac rehabilitation program or who have completed a pulmonary or cardiac rehabilitation program in the last 6 months prior to the screening visit (visit 1).
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
• Patients with symptomatic prostatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications.
• Patients with known narrow-angle glaucoma.
• Patients with a theophylline level \> 5.0 μg/ml.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: January 1, 2004
• Primary Completion: March 1, 2004
• Last Updated: June 24, 2014

Record last verified: 2014-06