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

Tracking Information

First Received Date ^ICMJE

March 27, 2007

Last Updated Date

April 4, 2007

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

LTD4 PC20

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00453778 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Shift in methacholine PD20

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Mild Asthma

Intervention ^ICMJE

Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00453778

Responsible Party

Study ID Numbers ^ICMJE

FMS40273, FMS40273

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

None

Investigators ^ICMJE

Principal Investigator:

GSK Clinical Trials, MD, prof.

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP