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Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02177344
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Low dose of Ipratropium bromide Drug: High dose of Ipratropium bromide Drug: Atrovent Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 646 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 1998
Actual Primary Completion Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Low dose of ipratropium bromide Drug: Low dose of Ipratropium bromide
One puff, 4 times daily by oral inhalation

Experimental: High dose of Ipratopium bromide Drug: High dose of Ipratropium bromide
One puff, 4 times daily by oral inhalation

Active Comparator: Atrovent Drug: Atrovent
Two puffs, 4 times daily by oral inhalation

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Peak FEV1 post treatment [ Time Frame: up to day 169 ]
  2. Onset of therapeutic FEV1 response [ Time Frame: up to day 169 ]
  3. Duration of therapeutic FEV1 response [ Time Frame: up to day 169 ]
  4. Time to peak FEV1 response [ Time Frame: up to day 169 ]
  5. Total area under the curve from 0 to 6 hours (TAUC0-6) for average FEV1 response [ Time Frame: up to day 169 ]
  6. Average change in forced vital capacity (FVC) from zero to six hours [ Time Frame: up to day 169 ]
  7. Peak FVC post treatment [ Time Frame: up to day 169 ]
  8. Peak expiratory flow rate (PEFR) measured by the patient at home two times daily [ Time Frame: up to day 169 ]
  9. Amount of inhaled rescue medication used during the treatment period [ Time Frame: up to day 169 ]
  10. Concomitant medication usage during the treatment period including steroids [ Time Frame: up to day 169 ]
  11. Change in patient daily symptom assessments [ Time Frame: Baseline, up to day 169 ]
  12. Number of patients with adverse events [ Time Frame: Up to day 169 ]
  13. Changes in vital signs (pulse rate, blood pressure) [ Time Frame: Baseline, up to day 169 ]
  14. Changes in laboratory tests [ Time Frame: Baseline, day 169 ]
  15. Number of patients with significant changes in ECG (electrocardiogram) [ Time Frame: Baseline, day 169 ]
  16. Changes in physical examination [ Time Frame: Baseline, day 169 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Male or female patients 40 years of age or older
  3. 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
  4. Patients must be able to perform pulmonary function tests and maintain records during the study period, as required in the protocol
  5. Patients must be able to be trained in the proper use of an inhalation aerosol and the Respimat device
  6. 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:

  1. 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
  2. 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
  3. 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
  4. Patients who have a blood eosinophil count >= 0.6 GI/L. A repeat eosinophil count will not be conducted in these patients
  5. Patients with a recent history (i.e., one year or less) of myocardial infarction
  6. Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
  7. Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
  8. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  9. 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
  10. Patients with a history of asthma, allergic rhinitis or atopy
  11. Patients with a history of and/or active alcohol or drug abuse
  12. Patients with known active tuberculosis
  13. 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
  14. Patients with known symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
  15. Patients with known narrow-angle glaucoma, or raised intra-ocular pressure
  16. Patients with current significant psychiatric disorders
  17. Patients with regular use of daytime oxygen therapy
  18. Patients who are being treated with cromolyn sodium or nedocromil sodium
  19. Patients who are being treated with antihistamines
  20. 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
  21. Patients who are being treated with beta-blocker medication
  22. Patients who have had changes in their therapeutic plan within the last six weeks prior to the Screening Visit (Visit 1)
  23. 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®)
  24. Patients with known hypersensitivity to anticholinergic drugs or any other components of the ATROVENT® Solution including Benzalkonium chloride and Edetic acid
  25. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
  26. Previous participation in this study
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02177344    
Other Study ID Numbers: 244.2484
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action