Text Size

Study Of Patients With Allergic Rhinitis And Asthma

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00296530
First received: February 23, 2006
Last updated: May 15, 2009
Last verified: May 2009
History of Changes

February 23, 2006
May 15, 2009
September 2005
July 2007   (final data collection date for primary outcome measure)
Morning Peak Expiratory Flow
Same as current
Complete list of historical versions of study NCT00296530 on ClinicalTrials.gov Archive Site
Total Nasal Symptom Scores Morning Forced Expiratory Volume in 1 Second Asthma Symptom-Free Days Asthma Rescue-Free Days
Same as current
Not Provided
Not Provided
 
Study Of Patients With Allergic Rhinitis And Asthma
See Detailed Description

This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Asthma
  • Allergic Rhinitis
  • Drug: fluticasone propionate/salmeterol
  • Drug: fluticasone propionate
  • Drug: montelukast
    Other Names:
    • fluticasone propionate/salmeterol
    • fluticasone propionate
    • montelukast
Not Provided
Katial RK, Oppenheimer JJ, Ostrom NK, Mosnaim GS, Yancey SW, Waitkus-Edwards KR, Prillaman BA, Ortega HG. Adding montelukast to fluticasone propionate/salmeterol for control of asthma and seasonal allergic rhinitis. Allergy Asthma Proc. 2010 Jan;31(1):68-75.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have asthma for at least 3 months prior to the study.
  • Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
  • Currently have seasonal allergic rhinitis and have had seasonal onset of allergic rhinitis for at least the two previous allergy seasons.
  • Have a positive allergy skin test.

Exclusion Criteria:

  • Have a history of life-threatening asthma.
  • Been hospitalized for asthma within the 6 months prior to the study.
  • Have certain conditions that would make study participation unsafe.

The study doctor will evaluate other inclusion and exclusion criteria.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296530
ADA103578
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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