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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00441441