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
Completed
Completed
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:
Drug: fluticasone propionate
Drug: fluticasone propionate/salmeterol
Enrollment:
351
Observational study model:
Not applicable
Primary completion date:
2008-28-01
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
Location
GSK Investigational Site
Denver, Colorado, United States, 80206
Status
Study Complete
Location
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany, 21502
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Lake Oswego, Oregon, United States, 97035
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Study Complete
Location
GSK Investigational Site
Cortland, New York, United States, 14850
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Subiaco, Western Australia, Australia, 6001
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1E 2C2
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80401
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97213
Status
Study Complete
Location
GSK Investigational Site
Guetersloh, Nordrhein-Westfalen, Germany, 33332
Status
Study Complete
Location
GSK Investigational Site
Wesel, Nordrhein-Westfalen, Germany, 46483
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Study Complete
Location
GSK Investigational Site
Monterrey N.L, Nuevo León, Mexico, 64988
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Clayton, Victoria, Australia, 3168
Status
Terminated/Withdrawn
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
Completed
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.
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