Trial Outcomes & Findings for Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study- (NCT NCT00449046)
NCT ID: NCT00449046
Last Updated: 2015-05-06
Results Overview
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
COMPLETED
PHASE3
40 participants
Baseline to Week 24
2015-05-06
Participant Flow
Participant milestones
| Measure |
Salmeterol/Fluticasone Propionate
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Baseline characteristics by cohort
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Age, Continuous
|
8.7 years
STANDARD_DEVIATION 2.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Most Frequent Adverse Events - On Therapy
Laryngopharyngitis
|
8 Participants
|
|
Most Frequent Adverse Events - On Therapy
Bronchitis
|
8 Participants
|
|
Most Frequent Adverse Events - On Therapy
Nasopharyngitis
|
8 Participants
|
|
Most Frequent Adverse Events - On Therapy
Asthma
|
8 Participants
|
|
Most Frequent Adverse Events - On Therapy
Pharyngitis
|
6 Participants
|
|
Most Frequent Adverse Events - On Therapy
Pyrexia
|
5 Participants
|
|
Most Frequent Adverse Events - On Therapy
Otitis media
|
4 Participants
|
|
Most Frequent Adverse Events - On Therapy
Pharyngotonsillitis
|
3 Participants
|
|
Most Frequent Adverse Events - On Therapy
Laryngotracheo bronchitis
|
3 Participants
|
|
Most Frequent Adverse Events - On Therapy
Molluscum contagiosum
|
3 Participants
|
|
Most Frequent Adverse Events - On Therapy
Stomatitis
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety analysis was performed on the primary outcome measures, adverse events and on the safety population defined as all subjects who entered the treatment period and received at least one dose of study medication.
Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Serious Adverse Events (SAEs) - On Therapy
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and during Weeks 1-24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
|
32.9 L/min
Standard Deviation 34.48
|
SECONDARY outcome
Timeframe: Baseline and during Weeks 1-24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
|
12.50 Percent Change
Standard Deviation 11.294
|
SECONDARY outcome
Timeframe: Baseline and during Weeks 1-24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
|
31.2 L/min
Standard Deviation 29.28
|
SECONDARY outcome
Timeframe: Baseline and during Weeks 1-24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
|
-1.62 Percent Change
Standard Deviation 3.583
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Number of Participants With Symptom-Free Nights and Days
Baseline
|
29 Participants
|
|
Number of Participants With Symptom-Free Nights and Days
Week 24
|
31 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Efficacy analyses were performed on the secondary outcome measures and Full analysis set, defined as all the subjects who entered the treatment period, excluding all those who received no dose of study medication or who had no post-baseline data.
Rescue free means without the use of other medication.
Outcome measures
| Measure |
Salmeterol/Fluticasone Propionate
n=40 Participants
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Number of Participants With Rescue Medication-Free Nights and Days
Baseline
|
33 Participants
|
|
Number of Participants With Rescue Medication-Free Nights and Days
Week 24
|
32 Participants
|
Adverse Events
Salmeterol/Fluticasone Propionate
Serious adverse events
| Measure |
Salmeterol/Fluticasone Propionate
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
1/40
|
Other adverse events
| Measure |
Salmeterol/Fluticasone Propionate
Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
|
|---|---|
|
Infections and infestations
Laryngopharyngitis
|
20.0%
8/40
|
|
Infections and infestations
Bronchitis
|
20.0%
8/40
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
8/40
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
20.0%
8/40
|
|
Infections and infestations
Pharyngitis
|
15.0%
6/40
|
|
General disorders
Pyrexia
|
12.5%
5/40
|
|
Infections and infestations
Otitis Media
|
10.0%
4/40
|
|
Infections and infestations
Pharyngotonsillitis
|
7.5%
3/40
|
|
Infections and infestations
Laryngotracheo bronchitis
|
7.5%
3/40
|
|
Infections and infestations
Molluscum contagiosum
|
7.5%
3/40
|
|
Gastrointestinal disorders
Stomatitis
|
7.5%
3/40
|
|
Infections and infestations
Gastroenteritis
|
5.0%
2/40
|
|
Infections and infestations
Sinusitus
|
5.0%
2/40
|
|
Infections and infestations
tonsillitus
|
5.0%
2/40
|
|
Gastrointestinal disorders
Acetonaemic vomiting
|
5.0%
2/40
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
5.0%
2/40
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
2/40
|
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 centres of a multi-centre 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