Clinical trial NCT02182700: Efficacy and Safety of Combivent® Aerosol and Spacer, in Adult Patients With Moderate to Severe Asthma Crisis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 60 and 120 min after starting treatment
Secondary outcomes:
measure: Number of patients whose PEFR >= 60% within the first or the second hour
timeFrame: 60 and 120 min after start of treatment
measure: Hospitalisation period at the Intensive Care Unit (ICU)
timeFrame: up to 3rd hour after treatment
measure: Hospitalisation time at the general ward
timeFrame: up to 3rd hour after treatment
measure: Number of relapses and/or new episodes
timeFrame: 7 days after finishing treatment
Other outcomes:
Locations:
Study officials:
References: