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

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ClinicalTrials.gov Identifier: NCT02182700
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
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

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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bromides
Albuterol
Ipratropium
Anticonvulsants
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