- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172469
Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
June 20, 2014 updated by: Boehringer Ingelheim
A Comparison of 18 µg of Tiotropium Inhalation Capsules and Atrovent® Metered Dose Inhaler (2 Puffs of 20 µg, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
To compare the bronchodilator efficacy and safety of tiotropium inhalation capsules (18 µg once daily) and Atrovent® MDI (2 puffs of 20µg q.i.d.) among Filipino patients with COPD
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
215
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All patients had a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
- Patients had relatively stable airway obstruction with an FEV1 less than or equal to 65% of predicted normal and FEV1 less than or equal to 70% of FVC.
- Predicted normal values were based on the guidelines for standardised lung function testing in the Philippines.
- Male or female patients 40 years of age or older.
- Patients had a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
- Patients performed pulmonary function tests as required in the protocol.
- Patients were able to inhale medication from the Handihaler device and had a good technique of inhaling aerosol administered from an MDI.
- All patients signed an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.
Exclusion Criteria:
- Patients with significant diseases other than COPD were excluded. A significant disease was defined as a disease which in the opinion of the investigator could either put the patient at risk because of participation in the study or a disease which could 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, if the abnormality defined a disease listed as an exclusion criterion, were excluded.
- All patients with a serum glutamate oxalacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) twice the normal range, bilirubin 150% or creatinine 125% of the normal range were excluded regardless of the clinical condition. Repeated laboratory evaluations were not conducted in these subjects.
- Patients with a recent history (i.e. one year or less) of myocardial infarction were excluded.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy were excluded.
- Patients on regular use of daytime oxygen therapy were excluded.
- Patients with known active tuberculosis were excluded.
- Patients with a history of cancer within the last five years were excluded. 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 were excluded.
- Patients who have undergone pulmonary resection or a thoracotomy for any reason were excluded.
- Patients with an upper respiratory tract infection in the past 6 weeks prior to the screening visit (=visit 1) or during the baseline period of 2 weeks (run-in period) were excluded.
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system or the MDI were excluded.
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction were excluded.
- Patients with known narrow-angle glaucoma were excluded.
- Patients who were being treated with cromolyn sodium or nedocromil sodium were excluded.
- Patients who were being treated with antihistamines were excluded.
- Patients who were using oral corticosteroid medication at unstable (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 10 mg of prednisone per day or 20 mg every other day were excluded
- Pregnant or nursing women or women of childbearing potential who were not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm) were excluded.
- Patients with a history of asthma, allergic rhinitis or atopy or who had a blood total eosinophil count more or equal to 400 per μl (males) or more or equal to 320 per μl (females) were excluded. Repeated eosinophil counts were not conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse were excluded.
- Patients who had taken an investigational drug one month or six half-lives (whichever is greater) prior to the screening visit (=visit 1) were excluded.
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 & Placebo
|
|
Active Comparator: Atrovent & Placebo
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in trough Forced Expiratory Volume in one second (FEV1) - Trough FEV1 response -
Time Frame: Baseline and week 4
|
Baseline and week 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: 4 weeks
|
4 weeks
|
Through FEV1 response
Time Frame: week 2
|
week 2
|
FEV1 for the first 3 hours post drug administration on each pulmonary function test day
Time Frame: Day 1, 15 and 29
|
Day 1, 15 and 29
|
Trough Forced Vital Capacity (FVC) response
Time Frame: week 2 and 4
|
week 2 and 4
|
Individual FEV1 measurements
Time Frame: Day 1, 15 and 29
|
Day 1, 15 and 29
|
Individual FVC measurements
Time Frame: Day 1, 15 and 29
|
Day 1, 15 and 29
|
FVC for the first 3 hours post drug administration on each pulmonary function
Time Frame: Day 1, 15 and 29
|
Day 1, 15 and 29
|
Amount of salbutamol (MDI) use (rescue medication)
Time Frame: 4 weeks
|
4 weeks
|
Patient evaluation questionnaire (PEQ)
Time Frame: 4 weeks
|
4 weeks
|
PEFR (peak expiratory flow rate) measured by the patient
Time Frame: 4 weeks
|
4 weeks
|
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
May 1, 2001
Primary Completion (Actual)
April 1, 2002
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 (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- 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
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
- Bromides
- Ipratropium
Other Study ID Numbers
- 205.243
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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