Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis

Overview

Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.

Full Title of Study: “Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1999

Interventions

  • Drug: salbutamol sulfate + ipratropium bromide
    • 120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)

Arms, Groups and Cohorts

  • Experimental: Combivent® aerosol

Clinical Trial Outcome Measures

Primary Measures

  • Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
    • Time Frame: 60 and 120 min after starting treatment

Secondary Measures

  • Number of patients whose PEFR >= 60% within the first or the second hour
    • Time Frame: 60 and 120 min after start of treatment
  • Hospitalisation period at the Intensive Care Unit (ICU)
    • Time Frame: up to 3rd hour after treatment
  • Hospitalisation time at the general ward
    • Time Frame: up to 3rd hour after treatment
  • Number of relapses and/or new episodes
    • Time Frame: 7 days after finishing treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
  • Patients aged between18 to 40 years
  • Patients able to perform spirometry (PEFR and FEV1)
  • PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value
  • Patients able to sign witnessed informed consent

Exclusion Criteria

  • Patients with very severe or life threatening obstruction, manifested by:
  • Cyanosis of tongue and lips
  • Confusion, drowsiness, coma or exhaustion
  • Silent chest on auscultation or weak respiratory effort
  • PEFR < 25% the predicted normal value
  • Bradycardia (of less 60 beats/min)
  • Patients with a smoking history of more than 10 pack/years
  • Patients with chronic obstructive pulmonary disease (COPD)
  • Patients on treatment for or suspected as having glaucoma
  • Patients with uncontrolled hypertension
  • Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients
  • Female patients known or suspected to be pregnant or nursing
  • Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
  • Patients with a history of chest surgery
  • Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer
  • Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen
  • Patients who have previously recruited into this study
  • Patients who have been on other investigational drugs within three months prior to study entry
  • Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study
  • Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

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