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Advair Pediatric Once-Daily

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ClinicalTrials.gov Identifier: NCT00920959
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: FP 100mcg Drug: FSC 100/50mcg Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 908 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline at endpoint in daily PM PEF [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Various pulmonary function endpoints [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920959


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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SAS30021
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
This study has not been published in the scientific literature.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00920959     History of Changes
Other Study ID Numbers: SAS30021
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists