Use Of Oral Montelukast As Adjuvant Therapy In The Treatment Of Acute Asthma - Montelukast in Acute Asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003074-20-GB

Enrollment

130

Registered

2005-08-18

Start date

2005-08-17

Completion date

Unknown

Last updated

2012-04-24

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

Conditions

Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Singulair Product Name: Singulair Product Code: Singulair Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Montelukast CAS Number: 158966-92-8 Current Sponsor code: MEN004 Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Acute asthma with peak flow of less than 75% predicted Age 18 tom 65 Willingness to use effective contraception Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known or suspected hypersensitivity to Montelukast Known or suspected pregnancy Lactation Use of a LRA within the 2 weeks prior to presentation Any other significant concomitant respiratory disease Any clinically significant disease that may, in the opinion of the investigators, affect evaluation of the study Fever greater than 38C

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether Montelukast has a therapeutic role in the treatment of acute asthma;Secondary Objective: We will look at the impact of montelukast on reliever inhaler use over the following week. We will look at how the addition of montelukast affects symptom scores over the week following an exacerbation compared to placebo. We will look at how the addition of montelukast affects peak flow readings over the week following an exacerbation. We will look at how the addition of montelukast affects the FEV1 and FEF25-75 at 48hours and 1 week. We will look at its impact on measures of airway resistance and reactance at 48hours and 1 week. We will look at nitric oxide levels and how these differ between the montelukast and placebo groups. We will look at how peripheral eosinophil count varies between the groups over the course of a week. We will see if there is any difference in duration of inpatient stay between the groups. Another aim is to determine whether particular genetic subgroups derive more benefit than others when treated with Montelukast.;Primary end point(s): The primary endpoint will be change in Peak Expiratory Flow at 3 hours and 2 days	—

Measure

Time frame

Main Objective: To determine whether Montelukast has a therapeutic role in the treatment of acute asthma;Secondary Objective: We will look at the impact of montelukast on reliever inhaler use over the following week. We will look at how the addition of montelukast affects symptom scores over the week following an exacerbation compared to placebo. We will look at how the addition of montelukast affects peak flow readings over the week following an exacerbation. We will look at how the addition of montelukast affects the FEV1 and FEF25-75 at 48hours and 1 week. We will look at its impact on measures of airway resistance and reactance at 48hours and 1 week. We will look at nitric oxide levels and how these differ between the montelukast and placebo groups. We will look at how peripheral eosinophil count varies between the groups over the course of a week. We will see if there is any difference in duration of inpatient stay between the groups. Another aim is to determine whether particular genetic subgroups derive more benefit than others when treated with Montelukast.;Primary end point(s): The primary endpoint will be change in Peak Expiratory Flow at 3 hours and 2 days

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026