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

A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Mild Asthma
• Intervention / Treatment: Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

• Study Type: Interventional
• Enrollment: 14
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
LTD4 PC20

Secondary Outcome Measures

Outcome Measure
Shift in methacholine PD20

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: March 27, 2007
• First Submitted That Met QC Criteria: March 28, 2007
• First Posted (Estimate): March 29, 2007

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: methacholine; mild asthma; FLIXOTIDE; bronchial challenge; leukotriene D4
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: FMS40273