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Completed

NCT Number: NCT00453778

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mild Asthma Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLIXOTIDE Diskus 500 mcg (Fluticasone Propionate)

Drug

Primary outcomes

  1. LTD4 PC20

Secondary outcomes

  1. Shift in methacholine PD20

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Mar 29, 2007
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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