Asthma, Mild Asthma
Conditions
Keywords
mild asthma, FLIXOTIDE, methacholine, bronchial challenge, leukotriene D4
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.
Interventions
DRUGFLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LTD4 PC20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Shift in methacholine PD20 | — |
Outcome results
None listed