- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177344
Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease
July 16, 2014 updated by: Boehringer Ingelheim
A Six Month, Randomized, Double-blind (Within Formulation), Multiple Dose Trial to Compare the Safety and Efficacy of 20 mcg and 40 mcg of Ipratropium Bromide, as Delivered by the RESPIMAT Device, to 18 mcg ATROVENT® Inhalation Aerosol (x 2 Puffs) and Respective Placebos in Adults, With Chronic Obstructive Pulmonary Disease
The objective of this study is to confirm that chronic dosing of 20 mcg and 40 mcg of ipratropium bromide, administered via the RESPIMAT device, demonstrates clinical comparability and similar safety profiles to the 36 mcg dose of ATROVENT® Inhalation Aerosol (containing chlorinated fluorocarbons (CFC)) in patients with chronic obstructive pulmonary disease (COPD).
The efficacy and safety profiles of the two doses administered via the RESPIMAT device will also be compared to their respective placebo groups
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
646
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 must have a diagnosis of COPD and must meet the following spirometric criteria:
- Patients must have relatively stable, moderate to severe airway obstruction with a FEV1 =< 65% of predicted normal and FEV1 =< 70% of FVC
- Male or female patients 40 years of age or older
- Patients must have a smoking history of more than ten packs-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
- Patients must be able to perform pulmonary function tests and maintain records during the study period, as required in the protocol
- Patients must be able to be trained in the proper use of an inhalation aerosol and the Respimat device
- All patients must sign an Informed Consent Form prior to participation in the trial i.e., at least 24 hours prior to screening (Visit 1)
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 relevant abnormal baseline haematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
- All patients with a serum glutamate oxaloacetate transaminase > 80 U/L, serum glutamate pyruvate transaminase > 80 U/L, bilirubin > 34.2 µmol/L or creatinine > 176.8 µmol/L will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
- Patients who have a blood eosinophil count >= 0.6 GI/L. A repeat eosinophil count will not be conducted in these patients
- 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 or patients with any cardiac arrhythmia requiring drug therapy
- Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
- 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 of a thoracotomy for other reasons should be evaluated as per exclusion criterion #1
- Patients with a history of asthma, allergic rhinitis or atopy
- Patients with a history of and/or active alcohol or drug abuse
- Patients with known active tuberculosis
- Patients with an upper respiratory tract infection or COPD exacerbation in the past six weeks prior to the Screening Visit (Visit 1) or during the baseline period
- Patients with known symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
- Patients with known narrow-angle glaucoma, or raised intra-ocular pressure
- Patients with current significant psychiatric disorders
- Patients with regular use of daytime oxygen therapy
- 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 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
- Patients who are being treated with beta-blocker medication
- Patients who have had changes in their therapeutic plan within the last six weeks prior to the Screening Visit (Visit 1)
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®)
- Patients with known hypersensitivity to anticholinergic drugs or any other components of the ATROVENT® Solution including Benzalkonium chloride and Edetic acid
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Previous participation in this study
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Low dose of ipratropium bromide
|
One puff, 4 times daily by oral inhalation
|
Experimental: High dose of Ipratopium bromide
|
One puff, 4 times daily by oral inhalation
|
Active Comparator: Atrovent
|
Two puffs, 4 times daily by oral inhalation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve from 0 to 6 hours (AUC0-6) for average of forced expiratory volume in 1 second (FEV1)
Time Frame: up to day 169
|
up to day 169
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak FEV1 post treatment
Time Frame: up to day 169
|
up to day 169
|
Onset of therapeutic FEV1 response
Time Frame: up to day 169
|
up to day 169
|
Duration of therapeutic FEV1 response
Time Frame: up to day 169
|
up to day 169
|
Time to peak FEV1 response
Time Frame: up to day 169
|
up to day 169
|
Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response
Time Frame: up to day 169
|
up to day 169
|
Average change in forced vital capacity (FVC) from zero to six hours
Time Frame: up to day 169
|
up to day 169
|
Peak FVC post treatment
Time Frame: up to day 169
|
up to day 169
|
Peak expiratory flow rate (PEFR) measured by the patient at home two times daily
Time Frame: up to day 169
|
up to day 169
|
Amount of inhaled rescue medication used during the treatment period
Time Frame: up to day 169
|
up to day 169
|
Concomitant medication usage during the treatment period including steroids
Time Frame: up to day 169
|
up to day 169
|
Change in patient daily symptom assessments
Time Frame: Baseline, up to day 169
|
Baseline, up to day 169
|
Number of patients with adverse events
Time Frame: Up to day 169
|
Up to day 169
|
Changes in vital signs (pulse rate, blood pressure)
Time Frame: Baseline, up to day 169
|
Baseline, up to day 169
|
Changes in laboratory tests
Time Frame: Baseline, day 169
|
Baseline, day 169
|
Number of patients with significant changes in ECG (electrocardiogram)
Time Frame: Baseline, day 169
|
Baseline, day 169
|
Changes in physical examination
Time Frame: Baseline, day 169
|
Baseline, day 169
|
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
August 1, 1998
Primary Completion (Actual)
October 1, 1999
Study Registration Dates
First Submitted
June 24, 2014
First Submitted That Met QC Criteria
June 26, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Estimate)
July 17, 2014
Last Update Submitted That Met QC Criteria
July 16, 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
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Bromides
- Ipratropium
Other Study ID Numbers
- 244.2484
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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