Role of a drug called Montelukast, in acute asthma attack

Phase 3

Completed

• Conditions: Acute asthma; Respiratory - Asthma

• Registration Number: ACTRN12612000816853
• Lead Sponsor: Hilton Pharma (Pvt.) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All adults (age 16 and above), presenting to the ER or clinic of Aga Khan University Hospital (AKUH) with acute asthma exacerbation will be eligible for the study. They will be included if they have one or more features suggestive of ‘Acute asthma exacerbation’ according to GINA Guidelines and are hospitalized

Acute asthma exacerbation is characterized by a progressive increase in shortness of breath, cough, wheezing or chest tightness, and by a decrease in expiratory flow that can be quantified by simple measures of pulmonary function such as PEFR and FEV1. The severity of exacerbations may range from mild to life-threatening.
Hospital admission criteria will be standardized:
a.FEV1 < 70% predicted or PEFR < 300 L/min after receiving initial treatment in the emergency room
b.Respiratory rate > 24 breaths/min
c.No improvement in symptoms like shortness of breath or wheezing

Exclusion Criteria

1.Under 16 years of age
2.Pregnancy
3.Patients who do not consent to participate
4.History of tobacco use > 10 pack years
5.Any acute concurrent medical condition like pneumonia, congestive heart failure or pneumothorax on presentation to the ER
6.Concomitant therapy with systemic corticosteroids or le ukotriene modifiers at time of admission
7.FEV1 > 70% predicted or PEFR > 300 L/min
8. Acute respiratory failure requiring mechanical ventilation
9.Patients initially recruited in the study but improved after initial treatment and discharged from the ER

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1:Improvement in FEV1[Bedside spirometry to be done on admission and discharge using PiKo-1 (ATS and EU electronic peak flow monitor, Ferraris Respiratory Europe Ltd., Westford SG13 7NW, UK) software which measures the PEFR and FEV1. The PiKo-1 test to be repeated three times];Primary Outcome 2:Improvement in PEFR[Serial peak expiratory flow rate (PEFR) monitoring; <br>a baseline PEFR value to be obtained on enrolment, <br>then at 30, 60 and 90 minutes from the baseline value, followed by every 12 hours daily until discharge. <br>A minimum of 3 readings to be obtained each time before administration of bronchodilator and the best of 3 to be taken as the final value.]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1:Development of complications such as respiratory failure, cardiac arrest and/or death[Assessment of secondary outcomes to be done throughout the duration of hospital stay after initiation of therapy with oral montelukast sodium]