Last updated: 11/04/2018 11:59:56
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Possible Drug-Related Adverse Events
Timeframe: Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
Investigator Evaluations of Electrocardiogram (ECG) Results
Timeframe: Baseline and Week 12
Clinically Significant Unfavorable ECGs at Week 12
Timeframe: Baseline, Week 12
ECG Measures – Heart Rate
Timeframe: Baseline and Week 12
ECG Measures - QT interval
Timeframe: Baseline and Week 12
Cardiovascular Adverse Events Reported during Treatment Period
Timeframe: 12-Week Treatment Period
Cardiovascular Adverse Events Reported during the Post-Treatment Period
Timeframe: 5 Days after Week 12
Asthma Exacerbations: worsening of asthma requiring emergency intervention, hospitalization, or treatment with asthma medications prohibited by the protocols
Timeframe: Treatment period (weeks 1-12)
Number of participants with the indicated levels of 24-hour Urinary Cortisol Excretion
Timeframe: Baseline and week 12
Geometric mean values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
Timeframe: Baseline and Week 12
Geometric mean ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
Timeframe: Baseline and Week 12
Number of participants with the indicated levels of 24 hour Urinary Cortisol Excretion by Spacer Use
Timeframe: Baseline and Week 12
Geometric mean values of 24 hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
Timeframe: Baseline and Week 12
Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
Timeframe: Baseline and Week 12
Secondary outcomes:
Clinic Morning (AM) Forced Expiratory Volume in participants 6-11 years
Timeframe: Baseline and week 12
AM Peak Expiratory Flow
Timeframe: Baseline and 12-Week Treatment Period
Asthma Symptom Scores
Timeframe: Baseline and 12-Week Treatment Period
Percentage of Symptom free days
Timeframe: Baseline and 12-Week Treatment Period
Albuterol Use
Timeframe: Baseline and 12-Week Treatment Period
Percent of Albuterol-free Days
Timeframe: Baseline and 12-Week Treatment Period
Interventions:
Enrollment:
351
Primary completion date:
2008-28-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Li JS, Qaqundah PY, Weinstein SF, LaForce CF, Ellsworth AV, Ortega HG, Ferro TJ. Fluticasone propionate/salmeterol combination in children with asthma: key cardiac and overall safety results. Clin Res Reg Affairs 2010;27(3):87-95.
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, fluticasone propionate/salmeterol/norflurane, norflurane, salmeterol
Collaborators
Not applicable
Study date(s)
February 2007 to January 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- Must have asthma.
- Must be currently taking an inhaled corticosteroid.
- Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
- Has a current ear or respiratory tract infection.
Inclusion and exclusion criteria
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).
Trial location(s)
Location
GSK Investigational Site
Parkville, Victoria, Australia, 3052
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-28-01
Actual study completion date
2008-28-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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