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A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50m

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Trial Conditions
  • Asthma
What is the purpose of this trial?

To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
4  - 11 

Gender:
Both

Eligibility

Inclusion Criteria:

- Out-patients

- Asthma diagnosis

- Reversibility

- Short-acting beta-agonist or asthma controlled medication use

Exclusion Criteria:

- Life-threatening asthma

- Specified asthma medications

- Chickenpox

- Drug allergy

- Respiratory infections

- Tobacco use

- Clinical laboratory abnormalities

- Ophthalmologic conditions

- Investigation medications

- Affiliation with investigator site

Gender: Both
Steward Physician(s)
  • GSK Clinical Trials
Trial Interventions
Drug
  • FP 100mcg
  • FSC 100/50mcg
  • Placebo
Physician Researcher

Investigator Name:

  • GSK Clinical Trials

Other Information

Sponsor: GlaxoSmithKline
Phase: Phase 3
Trial ID: NCT00920959
Volunteers:  Not Accepting Healthy Volunteers

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