A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 HFA Versus Fluticasone Propionate 100 HFA In Children With Asthma

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”

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.

Intervention(s) in this Clinical Trial

• Drug: fluticasone propionate 100mcg HFA
• Drug: fluticasone propionate/salmeterol 100/50mcg HFA

Primary Measures

• Possible Drug-Related Adverse Events
  • Time Frame: Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
    Safety Issue?: No
• Investigator Evaluations of Electrocardiogram (ECG) Results
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Clinically Significant Unfavorable ECGs at Week 12
  • Time Frame: Baseline, Week 12
    Safety Issue?: No
• ECG Measures - Heart Rate
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• ECG Measures - QT Interval
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Cardiovascular Adverse Events Reported During Treatment Period
  • Time Frame: 12-Week Treatment Period
    Safety Issue?: No
• Cardiovascular Adverse Events Reported During the Post-Treatment Period
  • Time Frame: 5 Days after Week 12
    Safety Issue?: No
• Asthma Exacerbations
  • Time Frame: Treatment period (weeks 1-12)
    Safety Issue?: No
• Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion
  • Time Frame: Baseline and week 12
    Safety Issue?: No
• Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Geometric Mean Ratio for Week12:Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

Secondary Measures

• Clinic AM Forced Expiratory Volume in Participants 6-11 Years
  • Time Frame: Baseline and week 12
    Safety Issue?: No
• AM Peak Expiratory Flow
  • Time Frame: Baseline and 12-Week Treatment Period
    Safety Issue?: No
• Asthma Symptom Scores
  • Time Frame: Baseline and 12-Week Treatment Period
    Safety Issue?: No
• Percentage of Symptom Free Days
  • Time Frame: Baseline and 12-Week Treatment Period
    Safety Issue?: No
• Albuterol Use
  • Time Frame: Baseline and 12-Week Treatment Period
    Safety Issue?: No
• Percent of Albuterol-free Days
  • Time Frame: Baseline and 12-Week Treatment Period
    Safety Issue?: No

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

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441441

Study ID Number: SFA106484

ClinicalTrials.gov Identifier: NCT00441441

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration