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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00453778
First received: March 27, 2007
Last updated: February 11, 2013
Last verified: February 2013

March 27, 2007
February 11, 2013
November 2002
May 2004   (final data collection date for primary outcome measure)
LTD4 PC20
Same as current
Complete list of historical versions of study NCT00453778 on ClinicalTrials.gov Archive Site
Shift in methacholine PD20
Same as current
Not Provided
Not Provided
 
A Study To Investigate The Effect Of Inhaled Fluticasone Propionate On The Bronchial Responsiveness To Leukotriene D4 In Asthmatics Patients
A Study to Investigate the Effect of Inhaled Fluticasone Propionate on the Bronchial Responsiveness to Leukotriene D4 in Asthmatics Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Asthma
  • Mild Asthma
Drug: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
Other Name: FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2004
May 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00453778
FMS40273
No
E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

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