Role of a drug called Montelukast, in acute asthma attack

A Randomized, double-blind, placebo-controlled trial to assess the effects of Oral Montelukast on forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR) in patients with acute asthma exacerbation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000816853

Acronym

Not applicable

Enrollment

100

Registered

2012-08-03

Start date

2005-02-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in clinical parameters along with PEFR and FEV1 were monitored.

Interventions

Patients in the treatment arm 1 will receive oral montelukast 10 mg first dose in the ER followed by 10 mg oral dose once a day in evening for the duration of stay in the hospital

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

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

Outcome results