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

NCT ID: NCT02182700

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combivent® aerosol

Group Type: EXPERIMENTAL

salbutamol sulfate + ipratropium bromide

Intervention Type: DRUG

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

Interventions

salbutamol sulfate + ipratropium bromide

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

Intervention Type: DRUG

Other Intervention Names

Combivent® aerosol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1012.32

Identifier Type: -

Identifier Source: org_study_id