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

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 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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: salbutamol sulfate + ipratropium bromide

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Combivent® aerosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	60 and 120 min after starting treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Primary Completion (Actual): December 1, 1999

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: 1012.32