A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mild Asthma
Intervention: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate) (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, prof., Principal Investigator, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: LTD4 PC20
Secondary outcome: Shift in methacholine PD20
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Stockholm SE17176, Sweden
Additional Information
Starting date: January 2003
Last updated: April 4, 2007
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