Working… Menu

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

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. Identifier: NCT02182700
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: salbutamol sulfate + ipratropium bromide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : July 1998
Actual Primary Completion Date : December 1999

Arm Intervention/treatment
Experimental: Combivent® aerosol Drug: salbutamol sulfate + ipratropium bromide
120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
Other Name: Combivent® aerosol

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT02182700     History of Changes
Other Study ID Numbers: 1012.32
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents