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

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Asthma

Treatments: Drug: salbutamol sulfate + ipratropium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02182700

1012.32

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Combivent® aerosol

Experimental group

Treatment:

Drug: salbutamol sulfate + ipratropium bromide