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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453778
• Other study ID #: FMS40273
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2007
• Last updated: February 11, 2013
• Start date: November 2002
• Est. completion date: May 2004

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2004
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Mild Asthma

Intervention

Drug:
• FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LTD4 PC20
Secondary	Shift in methacholine PD20