Effect of Tiotropium on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172300 | Completed Phase 3

• 1 other identifier: 205.131
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate whether tiotropium therapy can increase duration of steady-state exercise by decreasing dynamic and static lung hyperinflation in COPD patients.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Evaluation of submaximal exercise tolerance (as measured by endurance time during a constant work rate exercise test to symptom limitation)

  Day 42

Secondary Outcomes (21)

• Endurance time after first dosing

  Day 0 and 21

• Determination of breathlessness (dyspnea) during constant work rate exercise test as measured by the modified Borg Scale

  Day -10, -5, 0, 21 and 42

• Determination of leg discomfort during constant work rate exercise test as measured by the modified Borg Scale

  Day -10, -5, 0, 21 and 42

• Evaluation of dynamic lung hyperinflation during exercise

  Day -10, -5, 0, 21 and 42

• Evaluation of dynamic hyperinflation (DH) as negative change in inspiratory capacity (IC) from rest

  Day -10, -5, 0, 21 and 42

Study Arms (2)

Tiotropium

EXPERIMENTAL

Tiotropium inhalation capsules via HandiHaler

Drug: Tiotropium inhalation capsules

Placebo

PLACEBO COMPARATOR

Placebo inhalation capsules via HandiHaler

Drug: Placebo inhalation capsules

Interventions

Tiotropium inhalation capsules DRUG

Tiotropium

Placebo inhalation capsules DRUG

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients had to have a diagnosis of COPD. Patients had to meet the following spirometric and static lung volume criteria:
• Patients had to have relatively stable, mild (stage I according to the criteria of the American Thoracic Society (ATS); original trial protocol: moderate) to severe airway obstruction with an FEV1 less than or equal to 65% of predicted values. All patients had to have presence of lung hyperinflation as demonstrated by thoracic gas volume (TGV) / functional residual capacity (FRC) greater than or equal to 120% of predicted value as determined by body plethysmography at Visit 1 (day -15).
• Male or female patients ≥ 40 but ≤ 70 years old.
• Patients had to have a cigarette smoking history of more than 10 pack-years. A pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year.
• Patients had to be able to perform all specified procedures and maintain records during the study period as required in the protocol.
• Patients had to be able to inhale medication from the HandiHaler®.
• All patients had to sign an Informed Consent Form in accordance with Good Clinical Practice (GCP) and local legislative requirements prior to participation in the trial . i.e., prior to pre-study washout of their usual pulmonary medications.

You may not qualify if:

• Patients with significant diseases other than COPD were to be excluded. A significant disease was defined either as a disease, which in the opinion of the investigator might have put the patient at risk because of participation in the study or a disease, which might have influenced the results of the study or the patient's ability to participate in the study.
• All patients with a serum glutamic oxaloacetic transaminase (SGOT or AST) ≥ 1.5 of the upper limit of normal range (x ULN), serum glutamic pyruvic transaminase (SGPT or ALT) ≥ 1.5 x ULN, bilirubin ≥ 1.5 x ULN, or creatinine ≥ 1.5 x ULN were excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these subjects.
• Patients with a recent history (i.e., 1 year or less) of myocardial infarction.
• Patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise as indicated in Protocol Appendix four (see Section 9.5.1 and Appendices 16.1.1.1 and 16.1.1.2).
• Patients with regular use of daytime oxygen therapy. (In centers with significantly decreased barometric pressure, exercise tests can be done with inhaled oxygen).
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed.
• Patients with a history of life-threatening pulmonary obstruction or a history of cystic fibrosis or bronchiectasis.
• Patients with upper respiratory tract infection in the past 6 weeks prior to the Screening visit (Visit 1, day -15) or during the run-in period.
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not to be conducted in these patients.
• Patients who were being treated with cromolyn sodium or nedocromil sodium had to stop these medications 1 month before Visit 1 (day -15).
• Patients who were being treated with antihistamines (H1 receptor antagonists) or antileukotrienes had to stop these medications 1 month before Visit 1 (day -15).

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: June 1, 1999
• Primary Completion: November 1, 2000
• Last Updated: June 24, 2014

Record last verified: 2014-06