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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01462344




Registration number
NCT01462344
Ethics application status
Date submitted
27/10/2011
Date registered
31/10/2011
Date last updated
6/08/2018

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
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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
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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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Bangkok
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Pathumthani
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Warwickshire
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Barry
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Penzance
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Peterborough
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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
The purpose of this study is to assess whether the risk of serious asthma-related events
(asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11
years old taking inhaled fluticasone propionate/salmeterol combination is the same as those
taking inhaled fluticasone propionate alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01462344
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01462344