Last updated: 07/17/2024 15:42:01
Effects of a orally inhaled Fluticasone Furoate on growth velocity in Prepubertal, Paediatric Subjects with asthma over a year
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg once daily on Growth Velocity in Prepubertal, Paediatric Subjects with Asthma
Trial description: There is a regulatory requirement to evaluate the extent of reduction (if any) of growth velocity associated with inhaled corticosteroid (ICS) containing products that are to be administered to children, and to this end there is Food and Drug Administration (FDA) regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind (treatment period), parallel group, placebo controlled, multicentre study to assess the effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth velocity in prepubertal asthmatic children on a background therapy of open-label montelukast. This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50 mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The purpose of the study is to evaluate the magnitude of effect (with a level of precision) on growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU) and United States (US) regulatory requirements for the evaluation of potential growth suppression in children.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Growth Velocity (centimeter per year) over the double-blind treatment period, as determined by stadiometry
Timeframe: Up to 52 weeks
Secondary outcomes:
Percentage of participants below the third percentile of growth velocity during double-blind treatment period
Timeframe: Up to 52 weeks
Percentage of participants with change in growth velocity quartiles from Baseline to endpoint
Timeframe: Baseline and Endpoint (Week 28[Visit 12] up to and including Week 52 [Visit 18])
Growth velocity over the first 12 weeks of double-blind treatment period
Timeframe: Up to 12 weeks (Visit 8) of double-blind treatment period
Change in Height Standard Deviation Scores (SDS) from Baseline to Endpoint
Timeframe: Baseline (Week 0 [Visit 5]) and up to Endpoint (Week 52 [Visit 18])
Number of participants with non-serious adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 76 weeks
Number of participants with on-treatment asthma exacerbations over double-blind treatment period
Timeframe: Up to 52 weeks
Interventions:
Drug: Fluticasone furoate
Drug: Placebo
Drug: Montelukast
Drug: Short Acting Beta 2 Agonist
Enrollment:
477
Observational study model:
Not applicable
Primary completion date:
2021-09-04
Time perspective:
Not applicable
Clinical publications:
Bareille P, Birk R, Crawford J, Imber V, Karam-Absi Z, Olechowska B, et al. A multicenter randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of a 1-year regimen of orally inhaled fluticasone furoate 50 µg once daily on growth velocity in prepubertal, pediatric participants with well-controlled asthma. Pediatr Pulmonol.
DOI: 10.1002/ppul.26679
PMID: 37728224
Medical condition
Asthma
Product
fluticasone furoate, vilanterol
Collaborators
Not applicable
Study date(s)
July 2017 to June 2021
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
5 - 9 years
Accepts healthy volunteers
No
- Male or female subjects.
- Age: Males between 5 and <9 years old; Females between 5 and <8 years old.
- Growth Criteria: Any previous or current condition that affects growth, including sleep disorders, endocrine disorders, skeletal dysplasia, Turner and Noonan syndromes, Marfan, Beckwith–Wiedeman and Sotos syndromes, Klinefelter’s syndrome, coeliac disease, inflammatory bowel diseases and renal failure or any significant abnormality or medical condition that is identified at the screening medical assessment (including serious psychological disorder) that is likely to interfere with the conduct of the study.
- Subjects with premature adrenarche.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female subjects.
- Age: Males between 5 and <9 years old; Females between 5 and <8 years old.
- Subjects must be pre-pubertal (Tanner Stage 1).
- Height centile between 3% and 97% based on local growth charts.
- Subjects with body weight and body mass index that is between 3rd and 97th centile based on the United State (US) Centres for Disease Control and Prevention (CDC) standard statistics or any local standards outside the US.
- A documented history of symptoms consistent with a diagnosis of asthma for at least 6 months prior to Visit 1.
- A pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening) of between >=60% to <=95% predicted. There should be no short acting beta 2 agonist (SABA) use within 4 hours of this measurement.
- Able to replace their current SABA treatment with study supplied rescue albuterol/salbutamol provided at Visit 1 for use as needed for the duration of the study.
- A childhood asthma control test (cACT) score of >19.
- Subjects should have required at least one course of corticosteroid for their asthma (inhaled or oral) in the past year. -There must be no ICS use within 6 weeks of Visit 1 (Screening). -There must be no oral corticosteroids use within 12 weeks of Visit 1 (Screening).
- Using one or more of the following asthma therapies prior to entry into the study: Short acting beta-agonist (SABA) inhaler alone (example given [e.g.] salbutamol) on an as needed basis and/or regular non-ICS controller medications for asthma (e.g. cromones or leukotriene receptor antagonists).
- Written informed consent from at least one parent/care giver (legal guardian) and accompanying informed assent from the subject (where the subject is able to provide assent) prior to admission to the study. If applicable, subject must be able and willing to give assent to take part in the study according to local requirement. The study investigator is accountable for determining a child's capacity to assent for participation in a research study, taking into consideration any standards set by the responsible Independent Ethics Committee (IEC). Subject and their legal guardian(s) understand that they must comply with study medication administration regimens and study assessments including recording of symptom scores and rescue albuterol/salbutamol use, attending all study visits, and being accessible by telephone.
Exclusion criteria:
- Growth Criteria: Any previous or current condition that affects growth, including sleep disorders, endocrine disorders, skeletal dysplasia, Turner and Noonan syndromes, Marfan, Beckwith–Wiedeman and Sotos syndromes, Klinefelter’s syndrome, coeliac disease, inflammatory bowel diseases and renal failure or any significant abnormality or medical condition that is identified at the screening medical assessment (including serious psychological disorder) that is likely to interfere with the conduct of the study. -Subjects with premature adrenarche. -A child who is unable to stand, or who finds standing difficult due to illness or physical disabilities should be excluded.
- Disease Criteria: Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or use of a depot corticosteroid injection within 3 months or those requiring hospitalisation for asthma (within 6 months) prior to screening. -Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject’s asthma status or the subject’s ability to participate in the study.
- Clinical visual evidence of candidiasis at Visit 1 (Screening).
- Any significant abnormality or medical condition identified at the screening medical assessment that in the Investigator’s opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study.
- General: Prior use of any medication or treatment that might affect growth including, but not limited to: amphetamines, anticonvulsants, biphosphonates, calcitonin, calcitriol, erythropoietin, growth hormone, methylphenidate, phosphate binders, antithyroid drugs (e.g., Methimazole) or thyroid hormone.
- Use of any of the prohibited medications listed in the study protocol.
- Hypersensitivity: Known hypersensitivity to corticosteroids, leukotrienes, or any excipients in the ELLIPTA (ELLIPTA is a Glaxosmithkline owned trademark for dry powder inhaler) inhaler and study tablets.
- Milk Protein Allergy: History of severe milk protein allergy.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
- Children who are an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
- The Parent or Guardian has a history of known or suspected psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect: validity of consent to participate in the study; adequate supervision of the subject during the study; compliance of subject with study medication and study procedures (e.g. completion of daily diary, attending scheduled clinic visits); subject safety and well-being.
- Children in care: Children who are wards of the government or state are not eligible for participation in this study.
Trial location(s)
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68123
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1121ABE
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Georgia, United States, 30501
Status
Study Complete
Location
GSK Investigational Site
Homestead, Florida, United States, 33030
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Study Complete
Location
GSK Investigational Site
Lanús, Buenos Aires, Argentina, B1824KAJ
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Loxahatchee, Florida, United States, 33470
Status
Study Complete
Location
GSK Investigational Site
Middelburg, Mpumalanga, South Africa, 1055
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118-2040
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78230
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33710
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
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
Completed
Actual primary completion date
2021-09-04
Actual study completion date
2021-04-06
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (Argentina), Polish, Romanian, Russian, Afrikaans, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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