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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01462344




Registration number
NCT01462344
Ethics application status
Date submitted
27/10/2011
Date registered
31/10/2011

Titles & IDs
Public title
6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old
Scientific title
A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma
Secondary ID [1] 0 0
115358
Universal Trial Number (UTN)
Trial acronym
VESTRI
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 - ADVAIR 100/50mcg
Treatment: Drugs - ADVAIR 250/50mcg
Treatment: Drugs - FLOVENT 100mcg
Treatment: Drugs - FLOVENT 250mcg

Experimental: ADVAIR 100/50mcg - fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

Experimental: ADVAIR 250/50mcg - fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

Active comparator: FLOVENT 100mcg - fluticasone propionate (100) twice daily (AM and PM) for 6 months

Active comparator: FLOVENT 250mcg - fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months


Treatment: Drugs: ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months

Treatment: Drugs: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
Timepoint [1] 0 0
From Day 1 up to 6 months
Primary outcome [2] 0 0
Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period
Timepoint [2] 0 0
From Day 1 up to 6 months
Secondary outcome [1] 0 0
Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.
Timepoint [1] 0 0
From Day 1 up to 6 months
Secondary outcome [2] 0 0
Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period
Timepoint [2] 0 0
From Day 1 up to 6 months
Secondary outcome [3] 0 0
Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period
Timepoint [3] 0 0
From Day 1 up to 6 months
Secondary outcome [4] 0 0
Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period
Timepoint [4] 0 0
From Day 1 up to 6 months
Secondary outcome [5] 0 0
Percentage of Rescue-free Days Over the 6-month Study Treatment Period
Timepoint [5] 0 0
From Day 1 up to 6 months
Secondary outcome [6] 0 0
Percentage of Asthma Control Days Over the 6-month Study Treatment Period
Timepoint [6] 0 0
From Day 1 up to 6 months

Eligibility
Key inclusion criteria
1. Consent to participate in the study
2. Age 4-11 years old
3. Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation
4. Asthma diagnosis for at least 6 months
5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.
7. History of at least once occurrence of asthma exacerbation within the prior 12 months
8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of life-threatening asthma
2. Unstable asthma
3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
5. Respiratory infection
6. Subjects with only exercise-induced asthma
7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
13. Severe hypersensitivity to cow's milk proteins
14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
17. A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

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 4
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
17/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2015
Sample size
Target
Accrual to date
Final
6250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Westmead
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GSK Investigational Site - Auchenflower
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GSK Investigational Site - Subiaco
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GSK Investigational Site - Parkville
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GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2145 - Westmead
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4066 - Auchenflower
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6008 - Subiaco
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3052 - Parkville
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2031 - Randwick
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Taiwan
State/province [194] 0 0
Taichung
Country [195] 0 0
Taiwan
State/province [195] 0 0
Taipei
Country [196] 0 0
Taiwan
State/province [196] 0 0
Taoyuan
Country [197] 0 0
Thailand
State/province [197] 0 0
Bangkoknoi
Country [198] 0 0
Thailand
State/province [198] 0 0
Bangkok
Country [199] 0 0
Thailand
State/province [199] 0 0
Khon Kaen
Country [200] 0 0
Thailand
State/province [200] 0 0
Pathumthani
Country [201] 0 0
Thailand
State/province [201] 0 0
Phitsanulok
Country [202] 0 0
Thailand
State/province [202] 0 0
Ratchatewi
Country [203] 0 0
Ukraine
State/province [203] 0 0
Dnipropetrovsk
Country [204] 0 0
Ukraine
State/province [204] 0 0
Kharkiv
Country [205] 0 0
Ukraine
State/province [205] 0 0
Kryvyi Rih
Country [206] 0 0
Ukraine
State/province [206] 0 0
Kyiv
Country [207] 0 0
Ukraine
State/province [207] 0 0
Lviv
Country [208] 0 0
Ukraine
State/province [208] 0 0
Odesa
Country [209] 0 0
Ukraine
State/province [209] 0 0
Poltava
Country [210] 0 0
Ukraine
State/province [210] 0 0
Simferopol
Country [211] 0 0
Ukraine
State/province [211] 0 0
Sumy
Country [212] 0 0
Ukraine
State/province [212] 0 0
Uzhhorod
Country [213] 0 0
Ukraine
State/province [213] 0 0
Zaporizhia
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Derbyshire
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Glamorgan
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Northumberland
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Somerset
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Sussex East
Country [219] 0 0
United Kingdom
State/province [219] 0 0
Warwickshire
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Barry
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Bexhill-on-Sea
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Doncaster
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Glasgow
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Kent
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Leicester
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Macclesfield
Country [227] 0 0
United Kingdom
State/province [227] 0 0
Merseyside
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Penzance
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Peterborough
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Stockton on Tees
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Stoke on Trent
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

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/NCT01462344