- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172391
Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)
August 29, 2018 updated by: Boehringer Ingelheim
The Effects of Tiotropium Therapy on Airway Diameter in Patients With COPD (a Randomized, Double-blind, Placebo-controlled, Parallel-group Study)
Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
81
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 clinically significant abnormal baseline haematology, blood chemistry or urinalysis test results, if the abnormality defines a disease listed as an exclusion criterion
- 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 who have undergone thoracotomy with pulmonary resection. Patients with a history or a thoracotomy for other reason should be evaluated as per exclusion criterion no. 1
- 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
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3
- Patients with history of (past five years or less) and/or active alcohol or drug abuse
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Period (Visit 1)
- Patients who have participated in any pulmonary rehabilitation program for COPD within 6 weeks prior to Visit 1 or throughout the study
- Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tiotropium
Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days
|
|
Placebo Comparator: Placebo
Placebo inhalation powder capsules, one capsule once daily for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Time Frame: Day 28
|
Day 28
|
Trough resting IC
Time Frame: Day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FEV1 (Forced expiratory volume in one second)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
FVC (forced vital capacity)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
FEF50% (Forced Expiratory Flow, at 50% of FVC)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
FEF75% (Forced Expiratory Flow, at 75% of FVC)
Time Frame: Day 1, 14, 28
|
Day 1, 14, 28
|
SVC (Slow vital capacity)
Time Frame: Day 1, 14, 28
|
Day 1, 14, 28
|
Respiratory System Transfer Impedance (Respiratory Resistance)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
Airway Resistance (Raw)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
Thoracic Gas Volume (TGV)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
Specific Airway Conductance (SGaw)
Time Frame: Day 1, 14 and 28
|
Day 1, 14 and 28
|
Physician's Global Evaluation
Time Frame: Day 1 and 28
|
Day 1 and 28
|
Oxygen Saturation (SaO2) prior to six minute walk test
Time Frame: Day 1 and 28
|
Day 1 and 28
|
Oxygen Saturation (SaO2) post six minute walk test
Time Frame: Day 1 and 28
|
Day 1 and 28
|
IC prior to six minute walk test
Time Frame: Day 1 and 28
|
Day 1 and 28
|
IC post six minute walk test
Time Frame: Day 1 and 28
|
Day 1 and 28
|
Chronic Respiratory Questionnaire (CRQ)
Time Frame: Day 1 and 28
|
Day 1 and 28
|
Baseline Dyspnea Index (BDI)
Time Frame: Day 1
|
Day 1
|
Transition Dyspnea Index (TDI)
Time Frame: Day 28
|
Day 28
|
Change from baseline in seated blood pressure
Time Frame: Baseline, Day 1, 14 and 28
|
Baseline, Day 1, 14 and 28
|
Change from baseline in pulse rate
Time Frame: Baseline, Day 1, 14 and 28
|
Baseline, Day 1, 14 and 28
|
Occurrence of Adverse Events
Time Frame: until day 35
|
until day 35
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2000
Primary Completion (Actual)
August 1, 2001
Study Registration Dates
First Submitted
June 20, 2014
First Submitted That Met QC Criteria
June 20, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 29, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 205.218
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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