A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Asthma

Mild Asthma

Treatments

Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00453778

FMS40273

Details and patient eligibility

About

Investigate if asthmatics treated with FLIXOTIDE (FP) 500 mcg BID during 14 days get reduced bronchial reactivity after inhalation of Leukotriene D4. Two 14 days treatment periods where patients received FP 500 MCG BID and placebo. Washout at least 21 days between treatments. Bronchial challenge with methacholine and Leukotriene D4 were performed before the start of each treatment period and on treatment days 13 and 14 respectively.

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

Diagnosed history of asthma
Non smoker last two years
< 5 pack years
FEV1 >70% of predicted
Mild and stable asthma
Only using short acting b2-agonist as rescue for the last 4 weeks
Have a history of atopy.

Exclusion:

Any significant respiratory disease, other than asthma
Subjects with seasonal asthma may not be included if they are in their season
Use of oral or inhaled glucocorticosteroid for the last 3 months and long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and antileukotrienes within two weeks
Upper or lower RTI within 6 weeks
Evidence of any disease that in the investigators mind would affect the results of the study
Participating in another study within 4 weeks
Females who are pregnant, intend to be or who are lactating
Methacholine PD20 > 454mcg
Negative scin prick test