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
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
1 other identifier
interventional
351
13 countries
55
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Feb 2007
Shorter than P25 for phase_3 asthma
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
September 23, 2010
CompletedDecember 16, 2016
November 1, 2016
11 months
February 28, 2007
January 23, 2009
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Possible Drug-Related Adverse Events
Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.
Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
Investigator Evaluations of Electrocardiogram (ECG) Results
ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants' history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation.
Baseline and Week 12
Clinically Significant Unfavorable ECGs at Week 12
Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.
Baseline, Week 12
ECG Measures - Heart Rate
The range of heart rates for this study was between 49-144 beats per minute
Baseline and Week 12
ECG Measures - QT Interval
Fridericia's formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett's formula QTc=QT/squared root of the R-R interval.
Baseline and Week 12
Cardiovascular Adverse Events Reported During Treatment Period
Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.
12-Week Treatment Period
Cardiovascular Adverse Events Reported During the Post-Treatment Period
Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.
5 Days after Week 12
Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols
The Primary Investigator determined the severity of the exacerbation based on the participant's clinical presentation and the investigator's understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful.
Treatment period (weeks 1-12)
Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion
"Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.
Baseline and week 12
Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
Baseline and Week 12
Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).
Baseline and Week 12
Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use
AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. "Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.
Baseline and Week 12
Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.
Baseline and Week 12
Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).
Baseline and Week 12
Secondary Outcomes (6)
Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years
Baseline and week 12
AM Peak Expiratory Flow
Baseline and 12-Week Treatment Period
Asthma Symptom Scores
Baseline and 12-Week Treatment Period
Percentage of Symptom Free Days
Baseline and 12-Week Treatment Period
Albuterol Use
Baseline and 12-Week Treatment Period
- +1 more secondary outcomes
Study Arms (2)
Fluticasone propionate/salmeterol 100/50 HFA
EXPERIMENTALFluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily
Fluticasone propionate 100mcg HFA
EXPERIMENTALFluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily
Interventions
fluticasone propionate/salmeterol 100/50mcg HFA
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (55)
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Denver, Colorado, 80206, United States
GSK Investigational Site
Lakewood, Colorado, 80401, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Cortland, New York, 14850, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Lake Oswego, Oregon, 97035, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Germantown, Tennessee, 38138, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Parkville, Victoria, 3052, Australia
GSK Investigational Site
Subiaco, Western Australia, 6001, Australia
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2C2, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3T1, Canada
GSK Investigational Site
Mississauga, Ontario, L5A 3V4, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Viña del Mar, Región de Valparaíso, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, 8360156, Chile
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Wesel, North Rhine-Westphalia, 46483, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Ogre, LV5001, Latvia
GSK Investigational Site
Riga, LV1050, Latvia
GSK Investigational Site
Kaunas, LT-50009, Lithuania
GSK Investigational Site
Utena, LT-28151, Lithuania
GSK Investigational Site
Vilnius, LT-01117, Lithuania
GSK Investigational Site
Chihuahua City, Chihuahua, 31020, Mexico
GSK Investigational Site
Monterrey N.L, Nuevo León, 64988, Mexico
GSK Investigational Site
Mexico City, 04530, Mexico
GSK Investigational Site
México, 6720, Mexico
GSK Investigational Site
Lima, Lima Province, Lima 27, Peru
GSK Investigational Site
Lodz, 90-329, Poland
GSK Investigational Site
Rabka-Zdrój, 34-700, Poland
GSK Investigational Site
Moscow, 119435, Russia
GSK Investigational Site
Novosibirsk, 630099, Russia
GSK Investigational Site
St'Petersburg, 191144, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Murcia, 30120, Spain
GSK Investigational Site
San Javier (Murcia), 30720, Spain
Related Publications (1)
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.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A post-hoc evaluation confirmed that no clinically relevant ECG abnormalities were present. Differences in the primary and post-hoc analyses were associated with variation in the method of ECG interpretation and are not fully interpretable.
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
February 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
December 16, 2016
Results First Posted
September 23, 2010
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.