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

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: February 2001

Interventions

  • Drug: Ipratropium bromide HFA-134a inhalation aerosol
  • Drug: Atrovent® CFC inhalation aerosol
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Ipratropium bromide HFA-134a low
  • Experimental: Ipratropium bromide HFA-134a high
  • Active Comparator: Atrovent® CFC low
  • Active Comparator: Atrovent® CFC high
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Changes in peak FEV1 response
    • Time Frame: Baseline and after each drug administration
  • Onset of therapeutic FEV1 response
    • Time Frame: After each drug administration
  • Duration of therapeutic FEV1 response
    • Time Frame: After each drug administration
  • Time to peak FEV1 response
    • Time Frame: After each drug administration
  • Forced Vital Capacity (FVC) AUC0-6
    • Time Frame: After each drug administration
  • Changes from baseline in FEV1
    • Time Frame: Baseline and after each drug administration
  • Number of patients with adverse events
    • Time Frame: Up to 5 month after first drug administration
  • Peak FVC response
    • Time Frame: After each drug administration
  • Changes from baseline in FVC
    • Time Frame: Baseline and after each drug administration

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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