AsthmaPhase 3NCT02502734
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
A Phase 3 study testing Fluticasone furoate and Salbutamol in people with Asthma, run by GlaxoSmithKline at 1 site in Denmark.
Trial summary
This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone furoate and Salbutamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Sep 2015to 21 Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5 years to less than 12 years at Visit 1. At least 15 (25%) children of the total study population must be aged 5 to less than 8 years.
- Male or pre-menarchial female subjects.
- Subjects must be pre-adolescent without any signs of puberty (Tanner Stage 1).
- Normal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts.
- Have a documented diagnosis of persistent asthma, as defined by the National Institutes of Health for at least 3 months prior to the Screening Visit.
- A pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening) >=80% predicted. There should be no Short acting beta-agonist (SABA) use within 4 hours of this measurement.
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- Using one of the following asthma therapies prior to entry into the study: SABA inhaler alone (e.g. salbutamol) on an as required basis and/or Regular non-inhaled corticosteroid (ICS) controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or Previously treated with ICS (equipotent to inhaled budesonide <=400 micrograms (mcg) total daily dose). There must be no ICS use within 2 weeks of Visit 1 (Screening).
- Able to replace their current SABA treatment with study supplied rescue SABA provided at Visit 1 for use as needed for the duration of the study.
- 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: (1) If applicable, subject must be able and willing to give assent to take part in the study according to the local requirement. The study investigator is accountable for determining a child's capacity to assent to participation in a research study, taking into consideration any standards set by the responsible independent ethics committee (IEC). (2) Subject and their legal guardian(s) understand that the study requires them to be treated on an outpatient basis. (3) Subject and their legal guardian(s) understand that they must comply with study medication and study assessments including recording of peak expiratory flow and rescue SABA use, attending scheduled study visits, and being accessible by a telephone call.
Who cannot join
- A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s).
- Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or emergency room attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening.
- Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
- 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.
- Any fracture in the leg to be measured within 6 months prior to the screening visit.
- Any metabolic disorders or other diseases that may impact on normal growth patterns.
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- No major surgery requiring general anaesthesia for at least 3 months prior to the screening visit.
- No febrile illnesses with temperature >39 degree celsius for more than five consecutive days within the week preceding the Screening Visit.
- Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) 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.
- Clinical visual evidence of candidiasis at Visit 1 (Screening).
- Use of any of the prohibited medications listed in protocol.
- Strenuous physical exercise within 3 hours of Visit 1 (Screening)
- Drug allergies: Any adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e., lactose, FF).
- 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.
- Unable to use the ELLIPTA inhaler and peak flow meter correctly.
- An affiliation with the Investigator site: the parents/guardians or child is 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 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Two-way Crossover Study to Investigate the Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above.
ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.
- Conditions
- Asthma
- Being tested
- Fluticasone furoate, Placebo, Salbutamol
- Keywords
- inhaled corticosteroids, pediatric subjects, asthma, fluticasone furoate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoateDrug
FF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.
PlaceboDrug
Placebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.
SalbutamolDrug
Salbutamol will be provided as a inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Fluticasone furoate 50 μg and then placebo | Experimental | Subjects will receive oral inhalation of FF 50 μg administered via ELLIPTA, once daily (OD) for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo administered via ELLIPTA, OD for 14 days +/- 4 days in Period 2. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed. Receives: Drug: Fluticasone furoate; Drug: Placebo; Drug: Salbutamol |
| Sequence 2: Placebo and then fluticasone furoate 50 μg | Experimental | Subjects will receive oral inhalation of placebo administered via ELLIPTA OD for 14 days +/- 4 days in Period 1 followed by receive oral inhalation of FF 50 μg administered via ELLIPTA, OD for 14 days +/- 4 days. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed. Receives: Drug: Fluticasone furoate; Drug: Placebo; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.
Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.
Measured: Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.
Secondary outcomes (1)
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.
Measured: From the start of study treatment until follow-up (assessed up to 54 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start7 Sep 2015
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502734
- Sponsor's protocol ID
- 107112
- Status last verified
- Oct 2017
- First submitted
- 16 Jul 2015
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Wolthers OD, Stone S, Bareille P, Tomkins S, Khindri S. Knemometry Assessment of Short-term Growth in Children With Asthma Receiving Fluticasone Furoate for 2 Weeks: A Randomized, Placebo-controlled, Crossover Trial. Clin Ther. 2017 Jun;39(6):1191-1199. doi: 10.1016/j.clinthera.2017.04.011. Epub 2017 May 22.
PubMed 28545804
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Two-way Crossover Study to Investigate the Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT02502734
- Acronym / sponsor ID
- 107112
- Conditions
- Asthma
- Keywords
- inhaled corticosteroids, pediatric subjects, asthma, fluticasone furoate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2015 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above.
ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Fluticasone furoate 50 μg and then placebo | Experimental | Drug: Fluticasone furoate, Drug: Placebo, Drug: SalbutamolSubjects will receive oral inhalation of FF 50 μg administered via ELLIPTA, once daily (OD) for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo administered via ELLIPTA, OD for 14 days +/- 4 days in Period 2. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed. |
| Sequence 2: Placebo and then fluticasone furoate 50 μg | Experimental | Drug: Fluticasone furoate, Drug: Placebo, Drug: SalbutamolSubjects will receive oral inhalation of placebo administered via ELLIPTA OD for 14 days +/- 4 days in Period 1 followed by receive oral inhalation of FF 50 μg administered via ELLIPTA, OD for 14 days +/- 4 days. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged 5 years to less than 12 years at Visit 1. At least 15 (25%) children of the total study population must be aged 5 to less than 8 years.
- Male or pre-menarchial female subjects.
- Subjects must be pre-adolescent without any signs of puberty (Tanner Stage 1).
- Normal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts.
- Have a documented diagnosis of persistent asthma, as defined by the National Institutes of Health for at least 3 months prior to the Screening Visit.
Key exclusion criteria (20 listed)
- A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s).
- Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or emergency room attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening.
- Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis).
- 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.
- Any fracture in the leg to be measured within 6 months prior to the screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone furoateFF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA. | Drug | Sequence 1: Fluticasone furoate 50 μg and then placebo, Sequence 2: Placebo and then fluticasone furoate 50 μg |
| PlaceboPlacebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA. | Drug | Sequence 1: Fluticasone furoate 50 μg and then placebo, Sequence 2: Placebo and then fluticasone furoate 50 μg |
| SalbutamolSalbutamol will be provided as a inhaler. | Drug | Sequence 1: Fluticasone furoate 50 μg and then placebo, Sequence 2: Placebo and then fluticasone furoate 50 μg |
Primary outcome
Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.
Time frame: Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.
Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.
1 secondary outcome
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).
Time frame: From the start of study treatment until follow-up (assessed up to 54 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28545804Wolthers OD, Stone S, Bareille P, Tomkins S, Khindri S. Knemometry Assessment of Short-term Growth in Children With Asthma Receiving Fluticasone Furoate for 2 Weeks: A Randomized, Placebo-controlled, Crossover Trial. Clin Ther. 2017 Jun;39(6):1191-1199. doi: 10.1016/j.clinthera.2017.04.011. Epub 2017 May 22.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone furoate and Salbutamol in people with Asthma, run by GlaxoSmithKline at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry. (time frame: Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.