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Combivent® HFA-propelled Compared to CFC-propelled Metered Dose Inhaler in Patients With COPD (Chronic Obstructive Pulmonary Disease)

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ClinicalTrials.gov Identifier: NCT02182869
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Combivent® HFA inhalation aerosol Drug: Combivent® CFC inhalation aerosol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety Assessment of Cumulative Dose of Combivent® HFA-propelled Metered Dose Inhaler in Comparison to Combivent® CFC-propelled Metered Dose Inhaler. A Randomised, Double-blind, Active-controlled, Two-way Cross-over Study in COPD Patients
Study Start Date : April 2001
Actual Primary Completion Date : August 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Combivent® HFA Drug: Combivent® HFA inhalation aerosol
Active Comparator: Combivent® CFC Drug: Combivent® CFC inhalation aerosol



Primary Outcome Measures :
  1. Number of patients with clinically significant changes in electrocardiogram (ECG) parameters (ventricular rate, PQ, QRS, QT and QTc intervals) [ Time Frame: Baseline, up to 8 days after last treatment day ]
  2. Number of patients with clinically significant changes in vital signs (blood pressure, puls rate, respiratory rate) [ Time Frame: Baseline, up to 8 days after last treatment day ]
  3. Changes in intra ocular pressure (IOP) [ Time Frame: Baseline, up to 30 min after last drug administration ]
  4. Changes in serum potassium levels [ Time Frame: Baseline, up to 180 min after last drug administration ]
  5. Changes in serum glucose levels [ Time Frame: Baseline, up to 60 min after last drug administration ]
  6. Number of patients with clinically significant changes from baseline in clinical laboratory evaluations [ Time Frame: Baseline, 8 days after last treatment day ]
  7. Number of patients with adverse events including paradoxical bronchospasm [ Time Frame: Up to 8 days after last treatment day ]
  8. Number of patients with clinically significant changes from baseline in physical examination [ Time Frame: Baseline, 8 days after last treatment day ]

Secondary Outcome Measures :
  1. Change in FEV1 (forced expiratory volume in one second) [ Time Frame: Baseline, up to 180 min after last drug administration ]
  2. Change in FVC (forced vital capacity) [ Time Frame: Baseline, up to 180 min after last drug administration ]


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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. Male or female patients 40 years of age or older
  2. A diagnosis of COPD as defined by American Thoracic Society (ATS) criteria. Patients must have relatively stable, moderate to severe airway obstruction with a baseline FEV 1 <=65% of predicted normal and FEV1/FVC >=70%.
  3. A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
  4. Able to perform technical satisfactory pulmonary function test
  5. Able to be trained in the proper use of a MDI
  6. Having signed an informed consent from prior to participation in the trial
  7. Affiliation to the French social security system or beneficiary of such a system

Exclusion Criteria:

  1. Significant disease other than COPD. 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. Clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
  3. Serum glutamic oxaloacetic transaminase (SGOT) >80 IU/L; serum glutamic pyruvic transaminase (SGPT) >80IU/L, bilirubin >2.0mg/dL or creatinine >2.0mg/dL
  4. Serum potassium level above or below the normal range
  5. Total blood eosinophil count >=600/mm³
  6. Recent history (i.e., one year or less) of myocardial infarction
  7. Recent history (i.e., three years or less) of heart failure or any cardiac arrhythmia requiring drug therapy
  8. History of cancer, other than treated basal cell carcinoma, within the last five years
  9. History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
  10. History of thoracotomy with pulmonary resection. History or a thoracotomy for other reasons should be evaluated as per exclusion criteria no. 1
  11. History of asthma, allergic rhinitis or atopy
  12. History of or active alcohol or drug abuse
  13. Known active tuberculosis
  14. Upper respiratory tract infection or COPD exacerbation in the six weeks prior to screening visit or between the screening visit and visit 2
  15. Known symptomatic prostatic hypertrophy or bladder neck obstruction
  16. Known narrow-angle glaucoma
  17. Current significant psychiatric disorders
  18. Regular use of daytime oxygen therapy
  19. Use of beta-blocker medications, mono-amine oxidase inhibitors or tricyclic antidepressants
  20. Use of cromolyn sodium or nedocromil sodium
  21. Use of antihistamines.
  22. Use of oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose before screening visit or a change between the screening visit and visit2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20mg every other day
  23. Use of oral beta-adrenergics or long-acting beta-adrenergics such as salmeterol (Serevent®) and formoterol in the two weeks prior to the screening visit or between the screening visit and visit 2
  24. Changes in the therapeutic plan within the last six weeks prior to the screening visit or between the screening visit and visit 2, excluding changes from long acting or oral beta-adrenergics to short acting inhaled beta-adrenergics for purposes of this trial
  25. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception
  26. Known hypersensitivity to anti-cholinergic or beta-agonist drugs or any other component of either Combivent® formulations
  27. Use of an investigational drug within one month or six half lives prior to the screening visit
  28. Previous participation in this study
  29. Patient deprived of their freedom by a judicial or administrative decision
  30. Patient leaving in medical or social establishments
  31. Patient hospitalized for mental disorder without his (her) consent
  32. Patient under guardianship
  33. Patient in emergency situations

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182869     History of Changes
Other Study ID Numbers: 1012.43
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive