Trial Outcomes & Findings for Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma (NCT NCT02502734)
NCT ID: NCT02502734
Last Updated: 2017-11-17
Results Overview
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.
COMPLETED
PHASE3
60 participants
Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.
2017-11-17
Participant Flow
Study consisted of run-in period of two-weeks followed by two treatment periods of 14 days each (+/- 4 days) separated by a 14-day washout period and a follow-up visit of approximately 7 days post last dose. The total participation time in the study was approximately 9 Weeks.
A total of 60 participants were randomized to receive one of the two treatment sequences; placebo followed by inhaled fluticasone furoate or inhaled fluticasone furoate followed by placebo. All 60 participants received at least one single dose of study medication.
Participant milestones
| Measure |
Placebo Followed by Fluticasone Furoate
Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
|
Fluticasone Furoate Followed by Placebo
Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
|
|---|---|---|
|
Double-blind Treatment Period 1
STARTED
|
30
|
30
|
|
Double-blind Treatment Period 1
COMPLETED
|
29
|
30
|
|
Double-blind Treatment Period 1
NOT COMPLETED
|
1
|
0
|
|
Washout Period
STARTED
|
29
|
30
|
|
Washout Period
COMPLETED
|
28
|
30
|
|
Washout Period
NOT COMPLETED
|
1
|
0
|
|
Double-blind Treatment Period 2
STARTED
|
28
|
30
|
|
Double-blind Treatment Period 2
COMPLETED
|
28
|
30
|
|
Double-blind Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Followed by Fluticasone Furoate
Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
|
Fluticasone Furoate Followed by Placebo
Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
|
|---|---|---|
|
Double-blind Treatment Period 1
Adverse Event
|
1
|
0
|
|
Washout Period
Adverse Event
|
1
|
0
|
Baseline Characteristics
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
Baseline characteristics by cohort
| Measure |
Fluticasone Furoate and Placebo in Any of the Two Sequences
n=60 Participants
Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
|
|---|---|
|
Age, Continuous
|
8.7 Years
STANDARD_DEVIATION 1.53 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
59 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.Population: Growth Population
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.
Outcome measures
| Measure |
Placebo
n=58 Participants
Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
|
Fluticasone Furoate
n=58 Participants
Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
|
|---|---|---|
|
Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.
|
0.3638 millimeter per week
Standard Deviation 0.02793
|
0.3118 millimeter per week
Standard Deviation 0.02793
|
SECONDARY outcome
Timeframe: From the start of study treatment until follow-up (assessed up to 54 days)Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
|
Fluticasone Furoate
n=58 Participants
Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
|
|---|---|---|
|
Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).
|
15 Participants
|
7 Participants
|
Adverse Events
Placebo
Fluticasone Furoate
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
|
Fluticasone Furoate
n=58 participants at risk
Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.7%
1/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
|
Fluticasone Furoate
n=58 participants at risk
Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.3%
8/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
5.2%
3/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
5/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
6.9%
4/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
3/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
3.4%
2/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
3/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
3.4%
2/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
3.3%
2/60 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/58 • SAEs and non-serious AEs were collected from start of study medication through the Study Phase (7 weeks post-dose) and assessed up to 54 days. AEs reported during the wash-out and follow-up period are considered post-treatment and are not presented.
On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) are reported for the ITT Population, which comprises of all randomized participants who received at least one dose of study treatment.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER