Last updated: 07/17/2024 15:43:44
6-month safety and benefit study of ADVAIR in children 4-11 years oldVESTRI
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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)
Timeframe: From Day 1 up to 6 months
Number of participants with at least one asthma exacerbation over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Secondary outcomes:
Number of participants experiencing asthma-related deaths over the 6-month study treatment period.
Timeframe: From Day 1 up to 6 months
Number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Percentage of rescue-free days over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Percentage of asthma control days over the 6-month study treatment period
Timeframe: From Day 1 up to 6 months
Interventions:
Enrollment:
6250
Primary completion date:
2015-03-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
David A. Stempel, Stanley J. Szefler, Soren Pedersen, Robert S. Zeiger, Anne M. Yeakey, Laurie A. Lee, Andrew H. Liu, Herman Mitchell, Kenneth M. Kral, Ibrahim H. Raphiou, Barbara A. Prillaman, Kathleen S. Buaron, Suyong Yun Kirby, Steven J. Pascoe. Safety of adding salmeterol to fluticasone propionate in children with asthma. N Engl J Med. 2016;375(9):840-9.
Stanley Szefler, Ibrahim Raphiou, Robert S. Zeiger, David Stempel, Kenneth Kral, Steven Pascoe.Seasonal variation in asthma exacerbations in the AUSTRI and VESTRI studies .ERJ Open Res.2019;5:1-4
DOI: 10.1183/23120541.00153-2018
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Parexel
Study date(s)
November 2011 to November 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 11 years
Accepts healthy volunteers
No
- 1. Consent to participate in the study
- 2. Age 4-11 years old
- 1. History of life-threatening asthma
- 2. Unstable asthma
Inclusion and exclusion criteria
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)
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.
Trial location(s)
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87131
Status
Study Complete
Location
GSK Investigational Site
Alhambra, California, United States, 91801
Status
Study Complete
Location
GSK Investigational Site
Arlington, Texas, United States, 76018
Status
Study Complete
Location
GSK Investigational Site
Asheboro, North Carolina, United States, 27203
Status
Study Complete
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Showing 1 - 6 of 391 Results
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2015-03-11
Actual study completion date
2015-03-11
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
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