- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172443
Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease
August 29, 2018 updated by: Boehringer Ingelheim
Comparison of 18 mcg of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (2 Puffs of 20 mcg) in a Double Blind, Double Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study is to compare the bronchodilator efficacy and safety of tiotropium inhalation capsule (18 mcg once daily) and Atrovent MDI (2 puffs of 20 mcg q.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
50
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:
- COPD patients with an forced expiratory volume in one second (FEV1) <= 65% of predicted normal and FEV1 <= 70% of forced vital capacity (FVC)
- Male or female patients 40 years of age or older.
- Patient must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking on pack of cigarettes per day for a year.
- Patient must be able to perform pulmonary function test as required in the protocol.
- Patient must be able to inhale medication from the handihaler device and should have a good technique of inhaling aerosol administered from MDI.
- All patients must sign an informed consent from prior to participation in the trail, prior to pre-study washout of their usual pulmonary medication.
Exclusion Criteria:
- Patient with significant disease 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 result of the study or the patient's ability to participate in the study.
- Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
- All patients with a serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit will be excluded regardless of the clinical condition. Repeat laboratory evaluation will be not be conducted in these subjects.
- Patients with a recent history ( i.e. one year or less) of myocardial infarction.
- Patients with a recent history ( i.e. one year or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- 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, or history of cystic fibrosis or bronchiectasis.
- Patients who have undergone pulmonary resection or a thoracotomy for any reason.
- Patients with an upper respiratory tract infection in the past 2 weeks prior to the screening visit (= Visit 1) or during the baseline period of 2-weeks (run-in period).
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component 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.
- Patients using oral corticosteroid medication at unstable dosage (i.e. less than 6 weeks on a stable dose) or at a dose excess of the equivalent 10 mg of prednisone per day or 20 mg every day.
- Pregnant or nursing women or women of childbearing potential not using medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
- Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count >= 400 per microliter (males) or >= 320 per microliter (females). A repeat eosinophil count will not be conducted in these patients.
- Patients with a history and/or active alcohol or drug abuse.
- Patients who have taken an investigational drug on month or six half-lives (whichever is greater) prior to the screening visit (= Visit 1).
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 inhalation capsules
|
|
Active Comparator: Atrovent MDI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in trough forced expiratory volume in one second (FEV1)
Time Frame: baseline, day 29
|
baseline, day 29
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to day 29
|
up to day 29
|
Change from baseline in forced expiratory volume in one second (FEV1), area under curve from 0 to 3 hours post drug administration
Time Frame: baseline, day 29
|
baseline, day 29
|
Change from baseline in forced vital capacity (FVC), area under curve from 0 to 3 hours post drug administration
Time Frame: baseline, day 29
|
baseline, day 29
|
Change from baseline in total score of patient evaluation questionnaire
Time Frame: baseline, day 29
|
baseline, day 29
|
Number of rescue medications
Time Frame: Up to day 29
|
Up to day 29
|
Trough forced vital capacity (FVC) response
Time Frame: baseline, day 29
|
baseline, day 29
|
Changes in vital signs (blood pressure, pulse rate)
Time Frame: up to day 29
|
up to day 29
|
Changes in electrocardiogram
Time Frame: up to day 29
|
up to day 29
|
Changes in safety laboratory tests
Time Frame: up to day 29
|
up to day 29
|
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
June 1, 2001
Primary Completion (Actual)
May 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 (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
- 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
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
- Ipratropium
Other Study ID Numbers
- 205.232
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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