Advair Pediatric Once-Daily

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00920959
First received: June 12, 2009
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: FP 100mcg
Drug: FSC 100/50mcg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline at endpoint in daily PM PEF [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Various pulmonary function endpoints [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 908
Study Start Date: November 2001
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone propionate/salmeterol combination
study drug
Drug: FSC 100/50mcg
Once-daily dosing
Experimental: Fluticasone propionate
study drug
Drug: FP 100mcg
Once-daily dosing
Experimental: Placebo
placebo
Drug: Placebo
Once-daily dosing

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920959

  Show 149 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00920959     History of Changes
Other Study ID Numbers: SAS30021
Study First Received: June 12, 2009
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014