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Clinical Trial Results:
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

Summary
EudraCT number	2016-002551-22
Trial protocol	PL
Global end of trial date	04 Jun 2021

Results information
Results version number	v1(current)
This version publication date	19 Dec 2021
First version publication date	19 Dec 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

114971

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

GlaxoSmithKline

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS

Public contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-000431-PIP08-06

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

24 Aug 2021

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

04 Jun 2021

Was the trial ended prematurely?

No

Main objective of the trial

To evaluate the magnitude of effect (with a level of precision) of inhaled FF 50 micrograms (mcg) versus inhaled placebo once daily (OD) on growth velocity in prepubertal children over one year of treatment

Protection of trial subjects

In order to minimise pain and distress, it was agreed with both Food and drug Administration (FDA) and European Medicines Agency (EMA) not to do any blood tests in this study. Furthermore, participants were on a background of open-label montelukast tablets to avoid a “no treatment” arm to reduce the risk of uncontrolled asthma in the placebo group.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

20 Oct 2016

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 30

Country: Number of subjects enrolled

Poland: 70

Country: Number of subjects enrolled

Romania: 16

Country: Number of subjects enrolled

Russian Federation: 172

Country: Number of subjects enrolled

South Africa: 39

Country: Number of subjects enrolled

United States: 150

Worldwide total number of subjects

477

EEA total number of subjects

86

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

477

Adolescents (12-17 years)

0

Adults (18-64 years)

0

From 65 to 84 years

0

85 years and over

0

Subject disposition

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Recruitment details

This was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects of a one-year regimen of orally inhaled fluticasone furoate (FF) 50 micrograms (mcg) once daily on growth velocity in prepubertal, pediatric participants with asthma.

Screening details

Total 477 participants were enrolled in this study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Placebo was administered as dry white powder Lactose for inhalation using ELLIPTA inhaler

Investigational medicinal product name

Montelukast

Investigational medicinal product code

Other name

Pharmaceutical forms

Chewable tablet

Routes of administration

Oral use

Dosage and administration details

Montelukast was administered as 4 milligram (mg) in (5 year old participants) or 5 mg (>=6 year old participants) orally once daily in evening.

FF 50 mcg

Arm description

Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Arm type

Experimental

Investigational medicinal product name

Montelukast

Investigational medicinal product code

Other name

Pharmaceutical forms

Chewable tablet

Routes of administration

Oral use

Dosage and administration details

Montelukast was administered as 4 milligram (mg) in (5 year old participants) or 5 mg (>=6 year old participants) orally once daily in evening.

Investigational medicinal product name

Fluticasone Furoate

Investigational medicinal product code

Other name

Pharmaceutical forms

Inhalation powder

Routes of administration

Inhalation use

Dosage and administration details

Fluticasone furoate was administered as 50 microgram (mcg) dry white powder for inhalation using ELLIPTA inhaler

Number of subjects in period 1	Placebo	FF 50 mcg
Started	239	238
Completed	196	205
Not completed	43	33
Consent withdrawn by subject	30	21
Site Closed	12	11
Lost to follow-up	1	1

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Reporting group title

FF 50 mcg

Reporting group description

Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Reporting group values	Placebo	FF 50 mcg	Total
Number of subjects	239	238	477
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	239	238	477
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	0	0	0
From 65-84 years	0	0	0
85 years and over	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	6.1 ± 1.07	6.3 ± 1.02	-
Sex: Female, Male
Units: Participants
Female	84	94	178
Male	155	144	299
Race/Ethnicity, Customized
Units: Subjects
African American/African Heritage	13	13	26
Asian - Central/South Asian Heritage	0	1	1
Multiple	18	20	38
White - Arabic/North African Heritage	3	3	6
White - Mixed Race	1	0	1
White - White/Caucasian/European Heritage	204	201	405

End points

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Reporting group title

Placebo

Reporting group description

Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were greater than or equal to [>=] 6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Reporting group title

FF 50 mcg

Reporting group description

Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Primary: Growth Velocity (centimeter per year) over the double-blind treatment period, as determined by stadiometry

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End point title

Growth Velocity (centimeter per year) over the double-blind treatment period, as determined by stadiometry

End point description

Three reproducible height measurement were taken using stadiometer at each visit,recorded to nearest1/10th of centimeter.Each set of triplicate measurements was averaged to derive 1 estimated height per participant(Particip)per visit.Growth velocity(GV)was calculated over double-blind(DB)treatment period(upto52wks)by fitting regression line to averaged height measurement at each visit.Slope of regression line was participant’s GV for DB treatment period.Treatment policy estimand was assessed including allon&posttreatment data.Baseline was included as covariate calculated based on stadiometric height measurement recorded at V1(wk -16),3(wk-8),5(wk0),data from at least 2 of visits was used to fit simple linear regression line against time&slope of fitted regression line was GV.Growth Pop.was ITT particip.who have stadiometric height assessment from 3post-randomization,ontreatment clinic visit(including height measurement afterV5(wk0)upto,inclV18(wk52),without excl.)during DB period.

End point type

Primary

End point timeframe

Up to 52 weeks

End point values	Placebo	FF 50 mcg
Number of subjects analysed	226 ^[1]	231 ^[2]
Units: Centimeter per year
least squares mean (standard error)	6.065 ± 0.1090	5.905 ± 0.1078

Notes
[1] - Growth Population
[2] - Growth Population

Statistical Analysis 1

Comparison groups

FF 50 mcg v Placebo

Number of subjects included in analysis

457

Analysis specification

Pre-specified

Analysis type

other ^[3]

Method

Parameter type

Least Square (LS) Mean Difference

Point estimate

-0.16

Confidence interval

level

95%

sides

2-sided

lower limit

-0.462

upper limit

0.142

Notes
[3] - Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for baseline growth velocity, age at Visit 1, gender and country.

Secondary: Percentage of participants below the third percentile of growth velocity during double-blind treatment period

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End point title

Percentage of participants below the third percentile of growth velocity during double-blind treatment period

End point description

Three reproducible height measurements were taken using stadiometer at each visit & were recorded to nearest 1/10th of a centimeter.Each set of triplicate measurements was averaged to derive one estimated height per participant per visit. Growth velocity was calculated for each participant over double-blind(DB) treatment(upto 52weeks) period by fitting regression line to height measurements recorded for that participant during period. Each participant’s DB treatment period growth velocity was calculated based on all on &off treatment height data &was programmatically compared to data values from Standards from Birth to Maturity for Height,Weight,Height Velocity,established in British Children (1965)&further updated for North American children(1985)using 3rd percentile value of age closest to participant’s age at end of endpoint (i.e.either end of participant’s DB treatment period[Visit18 Wk 52]/withdrawal from study[Early Withdrawal Visit]).Percentage values presented is rounded off

End point type

Secondary

End point timeframe

Up to 52 weeks

End point values	Placebo	FF 50 mcg
Number of subjects analysed	226 ^[4]	231 ^[5]
Units: Percentage of participants	9	7

Notes
[4] - Growth Population
[5] - Growth Population

No statistical analyses for this end point

Secondary: Percentage of participants with change in growth velocity quartiles from Baseline to endpoint

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End point title

Percentage of participants with change in growth velocity quartiles from Baseline to endpoint

End point description

Growth velocity(GV)quartile(GVQ)(1st quartile(1Q)=1st-25th percentile,2Q=26th-50th percentile,3Q=51st-75th percentile,4Q=76th-100th percentile)was determined at Baseline&endpoint.Endpoint was slope of simple linear regression of average stadiometric height recorded at wk28upto wk52.Baseline GVwas calculated as slope from simple linear regression of average stadiometric height recorded at wk-16,-8&0.Baseline GV was programmatically compared to reference for standard height data using participant’s estimated age at wk0&age in reference data closest to actual age of participant to determine Baseline GVQ.Endpoint GV was programmatically compared to reference data using participant’s age at endpoint&age in reference data closest to actual age of participant to determine endpoint GVQ.Any increase/decrease indicates any increase/decrease in quartiles with reference to Baseline.Only participants with data available at specified datapoints were analyzed.Percentage value is rounded off.

End point type

Secondary

End point timeframe

Baseline and Endpoint (Week 28[Visit 12]up to and including Week 52 [Visit 18])

End point values	Placebo	FF 50 mcg
Number of subjects analysed	216 ^[6]	223 ^[7]
Units: Percentage of Participants
Any increase	33	32
Any decrease	34	38

Notes
[6] - Growth Population.
[7] - Growth Population.

No statistical analyses for this end point

Secondary: Growth velocity over the first 12 weeks of double-blind treatment period

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End point title

Growth velocity over the first 12 weeks of double-blind treatment period

End point description

Growth velocity(GV)was calculated for each participant over double-blind (DB) period by fitting regression line to height measurements recorded for participant during period.Slope of this regression line was participant’s GV for DB treatment period.In order to be included in this analysis,participant must have data from Visit(V)8(Wk12) stadiometric height assessment.Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at V1(wk -16),3(wk-8),&5(wk0),data from at least two of this visits were used to fit simple linear regression line against time&slope of fitted regression line was participant’s Baseline GV.All available height data collected during DB treatment period uptoV8(Wk12) while participant was on randomized DB treatment was considered.ANCOVA model was used to estimate mean treatment difference in GV over 1st 12wks of DB treatment period.Only those participants with data available at specified data points were analyzed.

End point type

Secondary

End point timeframe

Up to 12 weeks [Visit 8] of double-blind treatment period

End point values	Placebo	FF 50 mcg
Number of subjects analysed	210 ^[8]	211 ^[9]
Units: Centimeter per year
least squares mean (standard error)	6.222 ± 0.1845	6.281 ± 0.1841

Notes
[8] - Growth Population.
[9] - Growth Population.

Statistical Analysis 1

Comparison groups

Placebo v FF 50 mcg

Number of subjects included in analysis

421

Analysis specification

Pre-specified

Analysis type

other ^[10]

Method

Parameter type

LS Mean Difference

Point estimate

0.059

Confidence interval

level

95%

sides

2-sided

lower limit

-0.455

upper limit

0.572

Notes
[10] - Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country.

Secondary: Change in Height Standard Deviation Scores (SDS) from Baseline to Endpoint

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End point title

Change in Height Standard Deviation Scores (SDS) from Baseline to Endpoint

End point description

Each participant’s SDS for each of 3 required stadiometric height measurements was calculated as:(observed height measurement–standard median height for age at Visit [week-16]) divided by (/) ([standard 95th height percentile for age at visit–standard 5th height percentile for age at visit]/[2*1.645]).Standard median, 95th percentile, & 5th percentile values were obtained from standard tables (Guidance for Industry Orally Inhaled & Intranasal Corticosteroid). SDS for each height stadiometric measurement at each visit was calculated using percentiles from standard tables & averaged for each participant before being summarized by treatment group. A reduction in SDS over time indicates growth deceleration & an increase in SDS over time means growth acceleration.Baseline was defined as height SD score at Visit 5 (week 0). Endpoint was defined as height SD score at Visit 18 (week52) (on- & off-treatment data). Change from Baseline was calculated as Endpoint value minus Baseline value.

End point type

Secondary

End point timeframe

Baseline (Week 0 [Visit 5]) and up to Endpoint (Week 52 [Visit 18])

End point values	Placebo	FF 50 mcg
Number of subjects analysed	196 ^[11]	202 ^[12]
Units: Standard Deviation Score
arithmetic mean (standard deviation)	-0.02 ± 0.281	-0.04 ± 0.281

Notes
[11] - Growth Population.
[12] - Growth Population.

No statistical analyses for this end point

Secondary: Number of participants with non-serious adverse events (AEs) and serious adverse events (SAEs)

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End point title

Number of participants with non-serious adverse events (AEs) and serious adverse events (SAEs)

End point description

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as per investigator's judgement. Intent-to-Treat Population comprised of all randomized participants who received at least one dose of study treatment.

End point type

Secondary

End point timeframe

Up to 76 weeks

End point values	Placebo	FF 50 mcg
Number of subjects analysed	239 ^[13]	238 ^[14]
Units: Participants
Any SAEs	8	6
Any Non-serious AEs	105	99

Notes
[13] - Intent-to-Treat Population
[14] - Intent-to-Treat Population

No statistical analyses for this end point

Secondary: Number of participants with on-treatment asthma exacerbations over double-blind treatment period

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End point title

Number of participants with on-treatment asthma exacerbations over double-blind treatment period

End point description

An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a single depot corticosteroid injection, or an in-patient hospitalization or emergency department (ED) visit due to asthma that required systemic corticosteroids. Number of participants with on-treatment asthma exacerbations during double-blind treatment period is presented.

End point type

Secondary

End point timeframe

Up to 52 weeks

End point values	Placebo	FF 50 mcg
Number of subjects analysed	239 ^[15]	238 ^[16]
Units: Participants	22	7

Notes
[15] - Intent-to-Treat Population
[16] - Intent-to-Treat Population

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All cause mortality, non-serious adverse events (AEs) and serious AEs were collected up to 76 weeks

Adverse event reporting additional description

All-cause mortality, non-serious AEs and SAEs were collected in Intent-to-Treat Population which was comprised of all randomized participants who received at least one dose of study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

FF 50 mcg

Reporting group description

Participants received received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled FF 50 mcg was administered via ELLIPTA inhaler once daily in the morning for 52 weeks during double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 mg for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Reporting group title

Placebo

Reporting group description

Participants received a single-blind placebo inhaler during a 16-week run-in period. After run-in period inhaled placebo was administered once daily (OD) in the morning for 52 weeks during the double-blind treatment period. Participants also received open-label montelukast one tablet orally in the evening (4 milligrams [mg] for participants who were 5 years old and 5 mg for participants who were >=6 years old) as background therapy from the run-in period through to the end of follow-up (8 weeks) period.

Serious adverse events	FF 50 mcg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 238 (2.52%)	8 / 239 (3.35%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Fracture
subjects affected / exposed	0 / 238 (0.00%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Faecaloma
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Testicular appendage torsion
subjects affected / exposed	0 / 238 (0.00%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 238 (0.00%)	2 / 239 (0.84%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Adenoviral haemorrhagic cystitis
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastroenteritis norovirus
subjects affected / exposed	0 / 238 (0.00%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 238 (0.42%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	1 / 238 (0.42%)	0 / 239 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 238 (0.00%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus
subjects affected / exposed	0 / 238 (0.00%)	1 / 239 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	FF 50 mcg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	99 / 238 (41.60%)	105 / 239 (43.93%)
Nervous system disorders
Headache
subjects affected / exposed	10 / 238 (4.20%)	12 / 239 (5.02%)
occurrences all number	17	24
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	13 / 238 (5.46%)	18 / 239 (7.53%)
occurrences all number	15	23
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
subjects affected / exposed	8 / 238 (3.36%)	9 / 239 (3.77%)
occurrences all number	9	11
Cough
subjects affected / exposed	12 / 238 (5.04%)	15 / 239 (6.28%)
occurrences all number	15	23
Rhinorrhoea
subjects affected / exposed	3 / 238 (1.26%)	8 / 239 (3.35%)
occurrences all number	3	10
Infections and infestations
Bronchitis
subjects affected / exposed	9 / 238 (3.78%)	12 / 239 (5.02%)
occurrences all number	11	13
Influenza
subjects affected / exposed	11 / 238 (4.62%)	7 / 239 (2.93%)
occurrences all number	11	8
Nasopharyngitis
subjects affected / exposed	23 / 238 (9.66%)	25 / 239 (10.46%)
occurrences all number	26	31
Pharyngitis
subjects affected / exposed	3 / 238 (1.26%)	9 / 239 (3.77%)
occurrences all number	3	10
Respiratory tract infection viral
subjects affected / exposed	10 / 238 (4.20%)	4 / 239 (1.67%)
occurrences all number	11	7
Upper respiratory tract infection
subjects affected / exposed	29 / 238 (12.18%)	33 / 239 (13.81%)
occurrences all number	63	57
Rhinitis
subjects affected / exposed	16 / 238 (6.72%)	18 / 239 (7.53%)
occurrences all number	18	26

More information

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Were there any global substantial amendments to the protocol? Yes

04 Nov 2016

Amendment 1: Remove the term local growth charts and replace with United States Centers for Disease Control (US CDC) charts for inclusion criteria 4 and 5; Amend the text for inclusion criterion 7 to provide clarity on the time window used for re-scheduling the spirometry assessment at screening (Visit 1); Remove the term World Health Organisation (WHO) growth charts and replace with North America Longitudinal Standard Growth Velocity Charts for randomization criterion 1c; Amended typographical error in Section 5.5.4 and to clarify that the participant will be withdrawn from study treatment (for consistency with Section 5.5.1); Amend the text and provide clarity on the procedure around oropharyngeal exams in Section 7.3.5; Amend the time and events table to show an ‘x’ for body weight at Visit 3 as this was missing; Remove word “continuously” in Section 9.1; Add a supportive completer’s analysis of growth velocity over the 1-year double-blind treatment period, based on participants who completed the double-blind treatment period while remaining on study treatment, in Section 9.4.1.1

06 Mar 2019

Amendment 2: Removal of the upper limit of the Forced Expiratory Flow in 1 second (FEV1) from inclusion criterion 7 (Section 5.1); Removal of calcitriol from exclusion criteria 3 (Section 5.2) and from the prohibited medications Table 3 (Section 6.10.2); Update of text in Section 5.3 (Screening/Baseline/Run-in Failures) to allow rescreening of participants who have failed screening.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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