Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00441441
Registration number
NCT00441441
Ethics application status
Date submitted
28/02/2007
Date registered
1/03/2007
Date last updated
16/12/2016
Titles & IDs
Public title
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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
SFA106484
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Asthma
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Asthma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - fluticasone propionate
Treatment: Drugs - fluticasone propionate/salmeterol
Experimental: Fluticasone propionate/salmeterol 100/50 HFA - Fluticasone 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
Experimental: Fluticasone propionate 100mcg HFA - Fluticasone 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
Treatment: Drugs: fluticasone propionate
fluticasone propionate 100mcg HFA
Treatment: Drugs: fluticasone propionate/salmeterol
fluticasone propionate/salmeterol 100/50mcg HFA
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Possible Drug-Related Adverse Events
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Treatment period (weeks 1-12) and Post Treatment (=1 day after last time study drug)
Query!
Primary outcome [2]
0
0
Investigator Evaluations of Electrocardiogram (ECG) Results
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline and Week 12
Query!
Primary outcome [3]
0
0
Clinically Significant Unfavorable ECGs at Week 12
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, Week 12
Query!
Primary outcome [4]
0
0
ECG Measures - Heart Rate
Query!
Assessment method [4]
0
0
The range of heart rates for this study was between 49-144 beats per minute
Query!
Timepoint [4]
0
0
Baseline and Week 12
Query!
Primary outcome [5]
0
0
ECG Measures - QT Interval
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and Week 12
Query!
Primary outcome [6]
0
0
Cardiovascular Adverse Events Reported During Treatment Period
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
12-Week Treatment Period
Query!
Primary outcome [7]
0
0
Cardiovascular Adverse Events Reported During the Post-Treatment Period
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
5 Days after Week 12
Query!
Primary outcome [8]
0
0
Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Treatment period (weeks 1-12)
Query!
Primary outcome [9]
0
0
Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion
Query!
Assessment method [9]
0
0
"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.
Query!
Timepoint [9]
0
0
Baseline and week 12
Query!
Primary outcome [10]
0
0
Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline and Week 12
Query!
Primary outcome [11]
0
0
Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Baseline and Week 12
Query!
Primary outcome [12]
0
0
Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline and Week 12
Query!
Primary outcome [13]
0
0
Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline and Week 12
Query!
Primary outcome [14]
0
0
Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
Query!
Assessment method [14]
0
0
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).
Query!
Timepoint [14]
0
0
Baseline and Week 12
Query!
Secondary outcome [1]
0
0
Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years
Query!
Assessment method [1]
0
0
FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining "best effort" from 3 to 8 measurements. Week 12 is the measure taken at Week 12.
Query!
Timepoint [1]
0
0
Baseline and week 12
Query!
Secondary outcome [2]
0
0
AM Peak Expiratory Flow
Query!
Assessment method [2]
0
0
The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.
Query!
Timepoint [2]
0
0
Baseline and 12-Week Treatment Period
Query!
Secondary outcome [3]
0
0
Asthma Symptom Scores
Query!
Assessment method [3]
0
0
Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.
Query!
Timepoint [3]
0
0
Baseline and 12-Week Treatment Period
Query!
Secondary outcome [4]
0
0
Percentage of Symptom Free Days
Query!
Assessment method [4]
0
0
Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .
Query!
Timepoint [4]
0
0
Baseline and 12-Week Treatment Period
Query!
Secondary outcome [5]
0
0
Albuterol Use
Query!
Assessment method [5]
0
0
Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.
Query!
Timepoint [5]
0
0
Baseline and 12-Week Treatment Period
Query!
Secondary outcome [6]
0
0
Percent of Albuterol-free Days
Query!
Assessment method [6]
0
0
Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.
Query!
Timepoint [6]
0
0
Baseline and 12-Week Treatment Period
Query!
Eligibility
Key inclusion 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%.
Query!
Minimum age
4
Years
Query!
Query!
Maximum age
11
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
351
Query!
Recruitment in Australia
Recruitment state(s)
VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Clayton
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Parkville
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [3]
0
0
6001 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Oregon
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Pennsylvania
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Tennessee
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Vermont
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Newfoundland and Labrador
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Chile
Query!
State/province [17]
0
0
Región Metro De Santiago
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Valparaíso
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Santiago
Query!
Country [20]
0
0
Costa Rica
Query!
State/province [20]
0
0
San Jose
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Nordrhein-Westfalen
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Rheinland-Pfalz
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Schleswig-Holstein
Query!
Country [24]
0
0
Latvia
Query!
State/province [24]
0
0
Ogre
Query!
Country [25]
0
0
Latvia
Query!
State/province [25]
0
0
Riga
Query!
Country [26]
0
0
Lithuania
Query!
State/province [26]
0
0
Kaunas
Query!
Country [27]
0
0
Lithuania
Query!
State/province [27]
0
0
Utena
Query!
Country [28]
0
0
Lithuania
Query!
State/province [28]
0
0
Vilnius
Query!
Country [29]
0
0
Mexico
Query!
State/province [29]
0
0
Nuevo León
Query!
Country [30]
0
0
Mexico
Query!
State/province [30]
0
0
Chihuahua
Query!
Country [31]
0
0
Mexico
Query!
State/province [31]
0
0
Mexico city
Query!
Country [32]
0
0
Mexico
Query!
State/province [32]
0
0
Mexico
Query!
Country [33]
0
0
Peru
Query!
State/province [33]
0
0
Lima
Query!
Country [34]
0
0
Poland
Query!
State/province [34]
0
0
Lodz
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Rabka
Query!
Country [36]
0
0
Russian Federation
Query!
State/province [36]
0
0
Moscow
Query!
Country [37]
0
0
Russian Federation
Query!
State/province [37]
0
0
Novosibirsk
Query!
Country [38]
0
0
Russian Federation
Query!
State/province [38]
0
0
St'Petersburg
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Tomsk
Query!
Country [40]
0
0
Spain
Query!
State/province [40]
0
0
Murcia
Query!
Country [41]
0
0
Spain
Query!
State/province [41]
0
0
San Javier (Murcia)
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00441441
Query!
Trial related presentations / 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00441441
Download to PDF