Trial Outcomes & Findings for A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise (NCT NCT00118716)

NCT ID: NCT00118716

Last Updated: 2019-02-05

Results Overview

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 248 participants
• Primary outcome timeframe: Baseline and Week 4
• Results posted on: 2019-02-05

Participant Flow

The study was conducted from 23 December 2003 to 23 April 2006 across 51 sites in the United States (US) and a total of 248 participants were randomized.

Out of 789 participants screened, 389 participants were screen failures and 152 participants were Baseline failures.

Participant milestones

Measure	FSC 100/50 mcg BID Participants received Fluticasone Propionate/Salmeterol Combination (FSC) 100/50 micrograms (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days	FP 100 mcg BID Participants received Fluticasone Propionate (FP) 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Overall Study STARTED	124	124
Overall Study COMPLETED	111	102
Overall Study NOT COMPLETED	13	22

Reasons for withdrawal

Measure	FSC 100/50 mcg BID Participants received Fluticasone Propionate/Salmeterol Combination (FSC) 100/50 micrograms (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days	FP 100 mcg BID Participants received Fluticasone Propionate (FP) 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Overall Study Adverse Event	2	7
Overall Study Protocol Violation	5	4
Overall Study Withdrawal by Subject	0	1
Overall Study Exacerbation	2	2
Overall Study Discontinued by sponsor	1	1
Overall Study Non-compliance	1	3
Overall Study misrandomized	1	1
Overall Study Expired drug use	1	2
Overall Study Investigator discretion	0	1

Baseline Characteristics

A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

Baseline characteristics by cohort

Measure	FSC 100/50mcg BID n=124 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=124 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	Total n=248 Participants Total of all reporting groups
Age, Continuous	11.1 Years STANDARD_DEVIATION 3.33 • n=5 Participants	11.0 Years STANDARD_DEVIATION 3.57 • n=7 Participants	11.1 Years STANDARD_DEVIATION 3.45 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	50 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	74 Participants n=7 Participants	149 Participants n=5 Participants
Race/Ethnicity, Customized American Hispanic	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Arabic/North African	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	26 Participants n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized East & South East Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	81 Participants n=5 Participants	81 Participants n=7 Participants	162 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4

Population: Intent-to-Treat (ITT) population included all participants randomized to study drug. The number of participants available at that particular time point were used for analysis.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Maximal percent change in FEV1 following exercise challenge was defined as the percent change from pre-exercise baseline FEV1 to the minimum FEV1 collected within one hour following exercise challenge. Maximal percent change in FEV1 following exercise challenge was mean maximal percent change from pre-exercise baseline compared between treatment groups at Treatment Week 4. FEV1 was measured 5, 10, 15, 30, and 60 minutes post-exercise. The minimum FEV1 measured across these time points, regardless of any missing time points, will be used for the calculation of maximal percent change.

Outcome measures

Measure	FSC 100/50mcg BID n=113 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=104 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Maximal Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Following Exercise Challenge at Week 4	-9.5 Percent change Standard Error 0.83	-12.7 Percent change Standard Error 1.06

SECONDARY outcome

Timeframe: Immediately prior to dosing (0 time point), 30 minutes post-dose and 1, 2, 3, 4 hour post-dose on Day 1

Population: ITT population. Here, 'N' denotes participants with data available at the specified time point.

FEV1 AUC is mean AUC compared between treatment groups at Treatment Day 1. Baseline was defined as the pre-dose FEV1 measure from treatment Day 1. FEV1 AUC was calculated as the area of a trapezoid (calculated as the sum of the bases (top + bottom) divided by 2, then multiplied by width) above the baseline FEV1 area. For participants not completing a serial FEV1 measurement, the last observed post-dose FEV1 measurement was carried forward.

Outcome measures

Measure	FSC 100/50mcg BID n=119 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=120 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Four-hour Serial Post-dose FEV1 Area Under the Curve (AUC) on Treatment Day 1	0.70 Liters*hour Standard Error 0.067	0.30 Liters*hour Standard Error 0.059

SECONDARY outcome

Timeframe: Baseline and Up to Week 4

Population: ITT population. Here, 'N' denotes participants with data available at the specified time point.

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the morning. Change from baseline was calculated as the endpoint value minus the baseline value. For AM PEF, baseline was defined as the average of the AM PEF values recorded on the day of Visit 2 (7-14 [+ or -4] days after Visit1) plus the 6 preceding days since AM PEF was measured in the morning.

Outcome measures

Measure	FSC 100/50mcg BID n=117 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=113 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Change From Baseline in Morning Peak Expiratory Flow (AM PEF)	16.3 Liters/minute (L/min) Standard Error 2.99	9.1 Liters/minute (L/min) Standard Error 3.86

SECONDARY outcome

Timeframe: Baseline and up to Week 4

Population: ITT population. Here, 'N' denotes participants with data available at the specified time point.

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication after the symptom measurement and any rescue albuterol/salbutamol inhalation aerosol use. Each participant was instructed to perform triplicate PEF measurements in the evening. Change from baseline was calculated as the endpoint value minus the baseline value. Baseline was defined as the average of the values from the 7 days preceding Visit 2 (7-14 [+ or -4] days after Visit1) since these measures were derived from data collected in the evening.

Outcome measures

Measure	FSC 100/50mcg BID n=118 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=114 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Change From Baseline in Evening (PM) PEF	10.8 L/min Standard Error 2.96	7.6 L/min Standard Error 3.03

SECONDARY outcome

Timeframe: Up to Week 4

Population: ITT population. Here, 'N' denotes participants with data available at the specified time point.

A rescue-free day was defined as a day when no supplemental albuterol was taken (i.e., 0 puffs recorded for both AM and PM assessments of albuterol use in the daily diary). Percent of rescue-free days was calculated as the number of rescue-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.

Outcome measures

Measure	FSC 100/50mcg BID n=122 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=121 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Percent of Rescue-free Days	59.4 Percentage of days Standard Error 3.21	54.7 Percentage of days Standard Error 3.40

SECONDARY outcome

Timeframe: Up to Week 4

Population: ITT population. Here, 'N' denotes participants with data available at the specified time point.

A symptom-free day was defined as a day with no symptoms (i.e., a score of 0, indicating no asthma symptoms during the day or previous night, recorded in the daily diary). Percent of symptom-free days was calculated as the number of symptom-free days, divided by the total number of days in the treatment period, multiplied by 100 for each participant.

Outcome measures

Measure	FSC 100/50mcg BID n=122 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=121 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Percent of Symptom-free Days	27.3 Percentage of days Standard Error 3.10	28.6 Percentage of days Standard Error 3.04

SECONDARY outcome

Timeframe: Baseline (Week 0) and up to Week 4

Population: ITT Population. The PAQLQ was administered only to participants \>=7 years old.

PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Participants responded to each question on a 7-point scale (7= not bothered at all and 1= extremely bothered). The overall PAQLQ score is the mean of all 23 responses (minimum score 1= 5+8+10/23 and maximum score 7= 35+56+70/23) and the individual domain scores are the means of the items in those domains (minimum: 5/5, 8/8, 10/10 and maximum: 35/5, 56/8, 70/10). Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Endpoint was defined from the last questionnaire collected during the double-blind treatment period or discontinuation visit (up to Week 4).

Outcome measures

Measure	FSC 100/50mcg BID n=104 Participants Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=102 Participants Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Activity limitation week 2	0.78 Scores on a scale Standard Error 0.092	0.63 Scores on a scale Standard Error 0.100
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Activity limitation week 4	0.93 Scores on a scale Standard Error 0.113	0.75 Scores on a scale Standard Error 0.116
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Activity limitation endpoint	0.89 Scores on a scale Standard Error 0.104	0.67 Scores on a scale Standard Error 0.105
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Emotional function Week 2	0.44 Scores on a scale Standard Error 0.066	0.48 Scores on a scale Standard Error 0.089
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Emotional function Week 4	0.56 Scores on a scale Standard Error 0.096	0.47 Scores on a scale Standard Error 0.097
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Emotional function endpoint	0.53 Scores on a scale Standard Error 0.090	0.42 Scores on a scale Standard Error 0.088
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Symptoms Week 2	0.39 Scores on a scale Standard Error 0.085	0.49 Scores on a scale Standard Error 0.081
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Symptoms Week 4	0.52 Scores on a scale Standard Error 0.101	0.55 Scores on a scale Standard Error 0.109
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Symptoms Endpoint	0.48 Scores on a scale Standard Error 0.094	0.51 Scores on a scale Standard Error 0.101
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall score Week 2	0.49 Scores on a scale Standard Error 0.068	0.52 Scores on a scale Standard Error 0.074
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall score Week 4	0.62 Scores on a scale Standard Error 0.091	0.57 Scores on a scale Standard Error 0.092
Change From Baseline in Pediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall score Endpoint	0.59 Scores on a scale Standard Error 0.084	0.51 Scores on a scale Standard Error 0.084

Adverse Events

FSC 100/50mcg BID

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

FP 100mcg BID

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	FSC 100/50mcg BID n=124 participants at risk Participants received FSC 100/50 mcg one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.	FP 100mcg BID n=124 participants at risk Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Infections and infestations Upper respiratory tract infection	3.2% 4/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Nasopharyngitis	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Bronchitis	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Gastroenteritis	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Gastroenteritis viral	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Pharyngitis	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Pharyngitis streptococcal	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Fungal infection	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Herpes simplex	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Oral candidiasis	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Pneumonia	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Sinusitis	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Infections and infestations Tinea pedis	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.4% 3/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	2.4% 3/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Abdominal pain upper	2.4% 3/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Nausea	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Anal fissure	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Constipation	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Tooth impacted	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Gastrointestinal disorders Vomiting	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Nervous system disorders Headache	3.2% 4/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	4.8% 6/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Nervous system disorders Dizziness	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	3.2% 4/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Rash	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Dermatitis contact	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Skin laceration	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Contusion	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Excoriation	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Eye injury	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Injury, poisoning and procedural complications Joint sprain	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
General disorders Pyrexia	1.6% 2/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
General disorders Chest pain	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
General disorders Irritability	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Immune system disorders Food allergy	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Metabolism and nutrition disorders Increased appetite	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Psychiatric disorders Asperger's disorder	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.
Surgical and medical procedures Tongue tie operation	0.81% 1/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.	0.00% 0/124 • Adverse events and serious adverse events were collected from Visit 1 (Screening) until completion of the study (Up to 58 days) ITT population was used for the analysis of adverse events and serious adverse events.

Additional Information

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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