Last updated: 11/04/2018 07:44:36

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

GSK study ID
FMS40273
Clinicaltrials.gov ID
NCT00453778
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A study to investigate the effect of inhaled fluticasone propionate on the bronchial responsiveness to leukotriene D4 in asthmatics patients
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
Enrollment:
14
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
November 2002 to May 2004
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
No
  • Inclusion:
  • Diagnosed history of asthma
Inclusion and exclusion criteria
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

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-04-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website