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

NCT ID: NCT00453778

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2004-05-31

Brief Summary

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.

Conditions

Asthma; Mild Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

GSK Clinical Disclosure

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

FMS40273

Identifier Type: -

Identifier Source: org_study_id