Study to Assess the Safety of Ipratropium Bromide, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Overview

Study to assess the safety of two-week administration of 80 and 160 mcg of ipratropium bromide as delivered by the RESPIMAT® device and as determined by 24 hours ambulatory ECG monitoring in COPD patients. To assess the overall safety of the two doses of ipratropium bromide as delivered by the RESPIMAT® device when administered over a two-week period.

Full Title of Study: “A Double-blind, Placebo Controlled Trial to Assess the Safety of Two-week Administration of 80 mcg q.i.d. and 160 mcg q.i.d. of Ipratropium Bromide, as Delivered by the RESPIMAT® Device, in Patients With Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: February 1999

Interventions

  • Drug: Ipratropium Bromide low dose
  • Drug: Placebo
  • Drug: Ipratropium Bromide high dose

Arms, Groups and Cohorts

  • Experimental: Ipratropium Bromide low
    • delivered via RESPIMAT®
  • Experimental: Ipratropium Bromide high
    • delivered via RESPIMAT®
  • Placebo Comparator: Placebo
    • delivered via RESPIMAT®

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of clinical significant findings in 24-hour ambulatory ECG monitoring
    • Time Frame: Pre-treatment, on Day 7 and 13
  • Number of patients with adverse events
    • Time Frame: Up to 15 days after first drug administration
  • Number of patients with clinical significant findings in ECG
    • Time Frame: Up to 15 days after first drug administration
  • Number of patients with clinical significant findings in vital signs
    • Time Frame: Up to 15 days after first drug administration
  • Number of patients with clinical significant findings in laboratory tests
    • Time Frame: Up to day 15 after drug administration
  • Number of patients with paradoxical bronchospasm
    • Time Frame: Up to 15 days after first drug administration

Secondary Measures

  • FEV1 (forced expiratory volume in the first second) AUC0-4 (Area under the curve from 0 to 4 hours)
    • Time Frame: Pre-treatment, up to 4 h after drug administration on Day 1 and 14
  • Peak FEV1
    • Time Frame: On Day 1 and 14
  • Onset of therapeutic FEV1 response
    • Time Frame: On Day 1 and 14
  • Time to peak FEV1 response
    • Time Frame: On Day 1 and 14
  • AUC(0-6h) (Area under the plasma concentration-time curve from 0 to 6 h)
    • Time Frame: Day 14
  • Cmax (maximum plasma concentration)
    • Time Frame: Day 14
  • Cmin(0h) (minimum plasma concentration before inhalation)
    • Time Frame: Day 14
  • Cmin(6h) (minimum plasma concentration at 6 hours after inhalation)
    • Time Frame: Day 14
  • Ae(0-2h) (urine excretion between 0 to 2 h)
    • Time Frame: Day 14
  • Ae(0-6h) (urine excretion between 0 to 6 h)
    • Time Frame: Day 14

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 relatively stable, moderate to severe airway obstruction with an FEV1 <=65% of predicted normal and FEV1 <=70% of forced vital capacity (FVC). Predicted normal value will be calculated according to Morris – Males: FEV1 = 0.093 (Height in inches)-0.032 (age)-1.343 – Females: 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 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year – Patients must be able to perform pulmonary function tests (PFTs) and maintain records during the study period as required in the protocol – Patients must be able to be trained in the proper use of an inhalation aerosol and the RESPIMAT™ device – Patients must have a baseline electrocardiogram (ECG) with no clinical relevant arrhythmias or conduction system disease (e.g. right or left bundle branch block, second degree AV block or higher) – Patients must have an oxygen saturation of >=90% for >=92% of the recording time on overnight oximetry – All patients must sign an Informed Consent Form prior to participation in the trial (i.e., at least 24 hours (h) prior to the screening visit (Visit 1)) Exclusion Criteria:

  • Patients with clinically relevant diseases other than COPD will be excluded. A clinically relevant 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 with may influence the results of the study or patient's ability to participate in the study – Patients with a recent history (i.e. one year or less) of myocardial infarction – Patients with a recent history (i.e. one year or less) of heart failure or patients with any past history or active cardiac arrhythmia requiring drug therapy – Patients who have a pacemaker – Patients with clinically relevant abnormal 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 / Aspartate aminotransferase (SGOT/AST) >80 IU/L, serum glutamic pyruvic transaminase / Alanine transaminase (SGPT/ALT) >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 be not be conducted in these subjects – Patients who have a blood eosinophil count >=600/mm3. A Repeat eosinophil count will be not be conducted in these patients – Patients with a history of cancer, other than treated basal cell carcinoma, within the last 5 years – 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 of thoracotomy for other reason should be evaluated per exclusion criterion No. 1 – Patients with a history of asthma, allergic rhinitis or atopy – Patients with a history of and/or active alcohol or drug abuse – Patients with known active tuberculosis – Patients with an upper respiratory tract infection or COPD exacerbation in the past 6 weeks prior to the screening visit (Visit 1) or during the baseline period – Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction – Patients with known narrow-angle glaucoma – Patients with current significant psychiatric disorders – Patients with regular use of daytime oxygen therapy – Patients who are being treated with cromolyn sodium or nedocromil sodium – Patients who are being treated with antihistamines – 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 – Patients who are being treated with beta-blocker medication – Patients who have had changes in their therapeutic plan within the last six weeks prior to the screening visit (visit 1) – Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g., oral contraceptive, intrauterine devices, diaphragm or Norplant®) – Patients with known hypersensitivity to ant cholinergic drugs or any other components of the ATROVENT® RESPIMAT™ solution including bacteriostatic agent benzalkonium chlorid (BAC) and edetic acid (EDTA) – Patients who have taken an investigational drug within 1 month or 6 half-lives (whichever is longer) prior to the screening visit (visit1) – Previous participation in this study

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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