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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
SFA106484
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Possible Drug-Related Adverse Events
Timepoint [1] 0 0
Treatment period (weeks 1-12) and Post Treatment (=1 day after last time study drug)
Primary outcome [2] 0 0
Investigator Evaluations of Electrocardiogram (ECG) Results
Timepoint [2] 0 0
Baseline and Week 12
Primary outcome [3] 0 0
Clinically Significant Unfavorable ECGs at Week 12
Timepoint [3] 0 0
Baseline, Week 12
Primary outcome [4] 0 0
ECG Measures - Heart Rate
Timepoint [4] 0 0
Baseline and Week 12
Primary outcome [5] 0 0
ECG Measures - QT Interval
Timepoint [5] 0 0
Baseline and Week 12
Primary outcome [6] 0 0
Cardiovascular Adverse Events Reported During Treatment Period
Timepoint [6] 0 0
12-Week Treatment Period
Primary outcome [7] 0 0
Cardiovascular Adverse Events Reported During the Post-Treatment Period
Timepoint [7] 0 0
5 Days after Week 12
Primary outcome [8] 0 0
Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols
Timepoint [8] 0 0
Treatment period (weeks 1-12)
Primary outcome [9] 0 0
Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion
Timepoint [9] 0 0
Baseline and week 12
Primary outcome [10] 0 0
Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
Timepoint [10] 0 0
Baseline and Week 12
Primary outcome [11] 0 0
Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
Timepoint [11] 0 0
Baseline and Week 12
Primary outcome [12] 0 0
Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use
Timepoint [12] 0 0
Baseline and Week 12
Primary outcome [13] 0 0
Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
Timepoint [13] 0 0
Baseline and Week 12
Primary outcome [14] 0 0
Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
Timepoint [14] 0 0
Baseline and Week 12
Secondary outcome [1] 0 0
Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years
Timepoint [1] 0 0
Baseline and week 12
Secondary outcome [2] 0 0
AM Peak Expiratory Flow
Timepoint [2] 0 0
Baseline and 12-Week Treatment Period
Secondary outcome [3] 0 0
Asthma Symptom Scores
Timepoint [3] 0 0
Baseline and 12-Week Treatment Period
Secondary outcome [4] 0 0
Percentage of Symptom Free Days
Timepoint [4] 0 0
Baseline and 12-Week Treatment Period
Secondary outcome [5] 0 0
Albuterol Use
Timepoint [5] 0 0
Baseline and 12-Week Treatment Period
Secondary outcome [6] 0 0
Percent of Albuterol-free Days
Timepoint [6] 0 0
Baseline and 12-Week Treatment Period

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%.
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2008
Sample size
Target
Accrual to date
Final
351
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [2] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [3] 0 0
GSK Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6001 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Chile
State/province [17] 0 0
Región Metro De Santiago
Country [18] 0 0
Chile
State/province [18] 0 0
Valparaíso
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago
Country [20] 0 0
Costa Rica
State/province [20] 0 0
San Jose
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Rheinland-Pfalz
Country [23] 0 0
Germany
State/province [23] 0 0
Schleswig-Holstein
Country [24] 0 0
Latvia
State/province [24] 0 0
Ogre
Country [25] 0 0
Latvia
State/province [25] 0 0
Riga
Country [26] 0 0
Lithuania
State/province [26] 0 0
Kaunas
Country [27] 0 0
Lithuania
State/province [27] 0 0
Utena
Country [28] 0 0
Lithuania
State/province [28] 0 0
Vilnius
Country [29] 0 0
Mexico
State/province [29] 0 0
Nuevo León
Country [30] 0 0
Mexico
State/province [30] 0 0
Chihuahua
Country [31] 0 0
Mexico
State/province [31] 0 0
Mexico city
Country [32] 0 0
Mexico
State/province [32] 0 0
Mexico
Country [33] 0 0
Peru
State/province [33] 0 0
Lima
Country [34] 0 0
Poland
State/province [34] 0 0
Lodz
Country [35] 0 0
Poland
State/province [35] 0 0
Rabka
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Moscow
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Novosibirsk
Country [38] 0 0
Russian Federation
State/province [38] 0 0
St'Petersburg
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Tomsk
Country [40] 0 0
Spain
State/province [40] 0 0
Murcia
Country [41] 0 0
Spain
State/province [41] 0 0
San Javier (Murcia)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00441441
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00441441