Intal and Singulair, alone and in combination in asthma provoked by inhalation of a sugar.

Phase 4

Completed

• Conditions: asthma; Respiratory - Asthma

• Registration Number: ACTRN12608000393358
• Lead Sponsor: Dr. Sandra D. Anderson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Clinical diagnosis of asthma, FEV1 =70% Predicted; adherent to prescribed ICS (inhaled corticosteroid) therapy for past 4 weeks, no chest infection in last 4 weeks, able to withhold current asthma medication for required time

Exclusion Criteria

pregnant females or those at risk of becoming pregnant, those breast feeding, current smokers or those with a recent (< 1 yr) past history of smoking, known sensitivity to either sodium cromoglycate or montelukast sodium or their components, taking of oral corticosteroids in the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to challenge with mannitol as expressed by the maximum percent fall in FEV1 (forced expiratory volume in the first second) from the prechallenge value.[approximately 23 minutes after commencement of challenge (the usual length of a challenge using 635 mg)];Area above the FEV1 (forced expiratory volume in the first second) time recovery curve to compare placebo, sodium cromoglycate, and sodium cromoglycate/montelukast sodium[30 minutes after end of challenge]

Secondary Outcome Measures

Name	Time	Method
time of recovery to within 5% of recovery to pre challenge FEV1 (forced expiratory volume in the first second)[Recovery to within 5% of prechallenge FEV1 (forced expiratory volume in the first second) took place between 5 and 50 minutes of cessation of challenge.]