This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed...
Date First Received: February 28, 2007
Last Updated: October 15, 2008
Verified by: GlaxoSmithKline, October 2008
Clinical Trial Phase: Phase 3 | Start Date: February 2007
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “A Randomized, Double-Blind, Parallel Group Study Evaluating the Safety of Fluticasone Propionate/Salmeterol 100/50mcg HFA (2 Inhalations of 50/25mcg) Twice Daily Compared With Fluticasone Propionate 100mcg HFA (2 Inhalations of 50mcg) Twice Daily in Subjects 4-11 Years of Age With Persistent Asthma”
Condition Keyword(s):
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: fluticasone propionate 100mcg HFA
- Drug: fluticasone propionate/salmeterol 100/50mcg HFA
Outcome Measures for this Clinical Trial
Primary Measures
- Adverse events Oropharyngeal examinations Asthma exacerbations Electrocardiograms
Secondary Measures
- This study has no secondary outcome measures.
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- Must have asthma.
- Must be currently taking an inhaled corticosteroid.
- Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
- Have a historical or current FEV1 or PEF reversibility of >=12%.
Exclusion criteria:
- Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
- Has a current ear or respiratory tract infection.
- Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 4 Years
Maximum Age for this Clinical Trial: 11 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441441
Study ID Number: SFA106484
ClinicalTrials.gov Identifier: NCT00441441
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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