- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260011
Study of the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to the Market Standard, Atrovent® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease
October 7, 2014 updated by: Boehringer Ingelheim
A Single-Dose, Double Blind, Crossover Trial to Determinate the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, Atrovent® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study was to compare the bronchodilator efficacy and safety of ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation Aerosol in COPD patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 2
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 stable, moderate to severe airway obstruction with an FEV 1 (forced expiratory volume in the first second) <=65% of predicted normal and FEV1 <=70% of FVC (Forced Vital Capacity)
- Males: Predicted normal FEV1=0.093 (height in inches) - 0.032(Age) - 1.343
- Females: Predicted normal FEV1=0.085 (height in inches) - 0.025(Age) - 1.692
- Male or female patients 40 years of age or older
- Patients must have a smoking history of more than ten pack-years
- Patients must be able to demonstrate an improvement in FEV1 >=015% within one hour after inhalation of two puffs of Atrovent® inhalation aerosol (21 mcg per puff)
- Patients must be able to satisfactorily administer the medication, perform pulmonary function test and maintain records during the study period as required in the protocol
- All patients must sign an informed consent form prior to participation in the trial (i.e., prior to pre-study washout of their usual pulmonary medications and prior to fasting for laboratory tests)
Exclusion Criteria:
- Patients with significant disease other than COPD were 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 clinical relevant baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
- All patients with serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80 IU/L, bilirubin >2.0 mg/dL, or creatinine >2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not to be conducted in these patients
- Patients with a history of asthma, allergic rhinitis or atopy or have a blood eosinophil count above 600/mm³. A repeat eosinophil count will not to 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, patients with any cardiac arrhythmia requiring therapy, patients receiving any systemic beta blocker and patients on chronic 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 reasons be evaluated as per exclusion criterion No. 1
- Patients with an upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit (vist1) or during the baseline period
- Patients with known hypersensitivity to anticholinergic drugs
- Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction
- Patients with known narrow-angle glaucoma
- Patients who are on cromolyn sodium or nedocromil sodium
- Patients who are on antihistamines
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptives, intrauterine devices, diaphragm or Norplant®)
- Patients who have taken an investigational drug within one month or 6 half-lives (whichever is longer) of the drug prior to the screening visit or patients currently enrolled in other research study
- Patients with a history of and/or active alcohol or drug abuse
Exclusion criteria for patients with allergies
- Patients with active infectious rhinitis (common cold) as determined by history and physical
- Patients with upper or lower respiratory infection at screening
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Ipratropium bromide HFA-134a low
|
|
Experimental: Ipratropium bromide HFA-134a high
|
|
Active Comparator: Atrovent® CFC low
|
|
Active Comparator: Atrovent® CFC high
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)
Time Frame: After each drug administration
|
After each drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in peak FEV1 response
Time Frame: Baseline and after each drug administration
|
Baseline and after each drug administration
|
Onset of therapeutic FEV1 response
Time Frame: After each drug administration
|
After each drug administration
|
Duration of therapeutic FEV1 response
Time Frame: After each drug administration
|
After each drug administration
|
Time to peak FEV1 response
Time Frame: After each drug administration
|
After each drug administration
|
Forced Vital Capacity (FVC) AUC0-6
Time Frame: After each drug administration
|
After each drug administration
|
Changes from baseline in FEV1
Time Frame: Baseline and after each drug administration
|
Baseline and after each drug administration
|
Number of patients with adverse events
Time Frame: Up to 5 month after first drug administration
|
Up to 5 month after first drug administration
|
Peak FVC response
Time Frame: After each drug administration
|
After each drug administration
|
Changes from baseline in FVC
Time Frame: Baseline and after each drug administration
|
Baseline and after each drug administration
|
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
October 1, 2000
Primary Completion (Actual)
February 1, 2001
Study Registration Dates
First Submitted
September 11, 2014
First Submitted That Met QC Criteria
October 7, 2014
First Posted (Estimate)
October 9, 2014
Study Record Updates
Last Update Posted (Estimate)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 7, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Respiratory Aspiration
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anesthetics
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Bromides
- Ipratropium
- Norflurane
Other Study ID Numbers
- 244.2498
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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