Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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: NCT02182674
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date August 31, 2018
Study Start Date  ICMJE October 2000
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
Average forced expiratory volume in the first second (FEV1) response calculated as area under the curve above test-day baseline from time 0 to 6 hours divided by six (AUC0-6h) [ Time Frame: 0, 1, 2, 3, 4, 5 and 6 hours post drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
  • onset of therapeutic FEV1 response [ Time Frame: up to 8 hours post drug administration ]
  • peak FEV1 [ Time Frame: up to 8 hours post drug administration ]
  • time to peak FEV1 [ Time Frame: up to 8 hours post drug administration ]
  • average of FEV1, pictured as area under the curve (AUC0-8h) [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration ]
  • individual FEV1 [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration ]
  • individual forced vital capacity (FVC) [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration ]
  • average of FVC, pictured as area under the curve (AUC0-8h) [ Time Frame: 0, 1, 2, 3, 4, 5, 6 and 8 hours post drug administration ]
  • peak FVC [ Time Frame: up to 8 hours post drug administration ]
  • ipratropium plasma concentration [ Time Frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration ]
  • albuterol plasma concentration [ Time Frame: pre-treatment; 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration ]
  • ipratropium amount from renal excretion (Ae0-2, Ae0-8) [ Time Frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration ]
  • albuterol amount from renal excretion (Ae0-2, Ae0-8) [ Time Frame: pre-treatment, 0 to 2 hours and 2 to 8 hours post drug administration ]
  • ipratropium plasma concentration (AUC0-8h) [ Time Frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration ]
  • albuterol plasma concentration (AUC0-8h) [ Time Frame: 5, 15, 30 minutes and 1, 2, 4 and 8 hours post drug administration ]
  • number of patients with Adverse Events [ Time Frame: up to day 49 after first drug administartion ]
  • change from baseline in pulse rate and blood pressure [ Time Frame: up to day 49 after first drug administartion ]
  • change from baseline in physical examination, laboratory test and 12-lead ECG [ Time Frame: up to day 49 after first drug administartion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A Randomized, Double Blind, Crossover, Placebo- and Active Controlled Dose Confirmation Study of Combivent HFA Inhalation Aerosol in Patients With COPD
Brief Summary Study to demonstrate the comparability of two puffs of Combivent hydrofluoroalkane (HFA) inhalation aerosol (18 mcg ipratropium bromide/100 mcg albuterol sulfate / per puff) to two puffs of the marketed chlorofluorocarbon (CFC) containing product, Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate / per puff). The dose response profile, safety and pharmacokinetics of Combivent HFA formulation are to be characterized.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Placebo Combivent HFA
  • Drug: Combivent HFA
  • Drug: Combivent (CFC)
  • Drug: Placebo Combivent (CFC)
Study Arms  ICMJE
  • Experimental: Combivent HFA
    Interventions:
    • Drug: Placebo Combivent HFA
    • Drug: Combivent HFA
  • Active Comparator: Combivent (CFC)
    Interventions:
    • Drug: Combivent (CFC)
    • Drug: Placebo Combivent (CFC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2014)
66
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients were to have a diagnosis of COPD and must have met the following criteria at visit 1: Patients were to have relatively stable, moderate to severe airway obstruction with a baseline forced expiratory volume in one second (FEV1) <=65 % of predicted normal and FEV1 / forced vital capacity (FVC) <=70 %.
  2. Patients must have demonstrated a >= 015 % improvement in baseline FEV1 within one hour after the inhalation of two puffs of Combivent (CFC) inhalation aerosol (18 mcg ipratropium bromide/103 mcg albuterol sulfate per actuation; ex-mouthpiece dose)
  3. Male or female patients 40 years of age or older.
  4. Patients must have had a smoking history of more than ten pack-year. A pack-year is defined as the equivalent of smoking on pack of 20 cigarettes per day for a year.
  5. Patients must have been able to perform technical satisfactory pulmonary function test.
  6. Patients must have been able to be trained in the proper use of a metered dose inhalator (MDI)
  7. All patients must have signed an informed consent form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.

Exclusion Criteria:

  1. Patients with significant disease other than COPD were to 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 clinical relevant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
  3. All patients with a 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 were to be excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these patients.
  4. Patients who had total blood eosinophil count >= 600/mm³. A repeat eosinophil count was not to 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 or a thoracotomy for other reasons were to be evaluated as per exclusion criteria no. 1.
  10. Patients with a history of asthma, allergic rhinitis or atopy.
  11. Patients with a history of 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 six weeks prior to screening visit (Visit 1) or between the screening visit and visit 2.
  14. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
  15. Patients with known narrow-angle glaucoma.
  16. Patients with current significant psychiatric disorder.
  17. Patients with regular use of daytime oxygen therapy.
  18. Patients who were being treated with beta blocker medication, mono amine oxidase (MAO) inhibitors or tricyclic antidepressants.
  19. Patients who were being treated with cromolyn sodium or nedocromil sodium.
  20. Patients who were being treated with antihistamines.
  21. Patients using 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 visit 2) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  22. Patients who had been treated with 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.
  23. Patients who have had changes in their 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.
  24. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
  25. Patients with known hypersensitivity to anticholinergic or beta-agonist drugs or any other component of either Combivent formulation.
  26. Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit.
  27. Previous participation in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182674
Other Study ID Numbers  ICMJE 1012.25
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP