Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT02172391 | Completed Phase 3

• 1 other identifier: 205.218
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)

  Day 28

• Trough resting IC

  Day 28

Secondary Outcomes (21)

• FEV1 (Forced expiratory volume in one second)

  Day 1, 14 and 28

• FVC (forced vital capacity)

  Day 1, 14 and 28

• FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)

  Day 1, 14 and 28

• FEF50% (Forced Expiratory Flow, at 50% of FVC)

  Day 1, 14 and 28

• FEF75% (Forced Expiratory Flow, at 75% of FVC)

  Day 1, 14, 28

Study Arms (2)

Tiotropium

EXPERIMENTAL

Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days

Drug: Tiotropium inhalation powder capsules

Placebo

PLACEBO COMPARATOR

Placebo inhalation powder capsules, one capsule once daily for 28 days

Drug: Placebo inhalation powder capsules

Interventions

Tiotropium inhalation powder capsules DRUG

Tiotropium

Placebo inhalation powder capsules 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 have a diagnosis of chronic obstructive pulmonary disease
• Male or female patients ≥ 40 years of age but ≤ 75 years old
• Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year
• Patients must be able to perform all specified procedures and maintain records during the study period as required in the protocol
• Patients must be able to inhale medication from the HandiHaler®
• All patients must sign a Patient Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications
• Patients must be willing to attend an outpatient clinic on a regular basis
• Patients must be able to walk 164 feet (50 meters) during the Six Minute Walk Test

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
• Patients with a serum glutamic-oxaloacetic transaminase (SGOT) ≥1.5 x Upper Limit of Normal Range (ULN), serum glutamic-pyruvic transaminase (SGPT) ≥1.5 x ULN, bilirubin ≥1.5 x ULN or creatinine ≥ 1.5 x ULN regardless of the clinical condition
• Patients with a recent history (i.e., one year or less) of myocardial infarction
• Patients with a recent history (i.e., three years or less) of heart failure, pulmonary edema or patients with any cardiac arrhythmia (with or without symptoms)
• Patients with regular use of daytime oxygen therapy
• Patients with known active tuberculosis
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are 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 six weeks prior to the Screening Visit or during the baseline 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 who are being treated with cromolyn sodium or nedocromil sodium
• Patients who are being treated with antihistamines (H1 receptor antagonists) or antileukotrienes and are not able to stop these medications 1 month before visit 1
• Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day

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
• 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: November 1, 2000
• Primary Completion: August 1, 2001
• Last Updated: August 31, 2018

Record last verified: 2018-08