CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 248 enrolled
Drug / intervention
Fluticasone propionate/salmeterol +1 moredrug
Likely dose
Fluticasone propionate/salmeterol 100/50mcg via DISKUS inhaler twice dailyAI-extracted
Key inclusion· 3
  • Diagnosed with persistent asthma for 3 months or longer
  • Experienced worsened asthma symptoms during physical activity
  • Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril)
Key exclusion· 4
  • Used systemic steroids (liquids, pills, or injections) to treat asthma within the previous 3 months
  • Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma
  • Admitted to a hospital within the previous 6 months due to asthma symptoms
  • Any poorly controlled medical conditions that may make study participation unsafe or inappropriate (e.g., cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00118716
NCT00118716Phase 4Completed

A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm

GlaxoSmithKline·interventional·Posted Jul 12, 2005·Updated Feb 5, 2019

In Brief

A Phase 4 clinical trial evaluating Fluticasone propionate/salmeterol and Fluticasone Propionate for Bronchospasm and Activity/Exercise Induced Bronchospasm. Completed, enrolled 248 participants across 50 sites.

Detailed Summary

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2005
Enrollment StartDec 23, 2003
Primary CompletionApr 1, 2006
Study CompletionApr 23, 2006
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.0 years ago

Interventions

Fluticasone propionate/salmeteroldrug

Fluticasone propionate/salmeterol

Fluticasone Propionatedrug

Fluticasone Propionate