Bronchial Asthma
Conditions
Keywords
salmeterol/fluticasone propionate combination, pediatric bronchial asthma
Brief summary
This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.
Interventions
DRUGGW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria for Entry in Run-in Period A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study: * Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of treatment period and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail during the study period. * Written informed consent must be obtained from the legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner. * An outpatient who has been treated with ICS (FP 100-200μg/day or equivalent) for at least 4 weeks prior to Visit 1. * Is suitable, in the investigator's/subinvestigator's judgment, for treatment with GW815SF HFA MDI 25/50μg (administered as 2 inhalations of 25/50μg) bid. * Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment. * Able to use MDI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment. Inclusion Criteria for Entry in Treatment Period A subject will be considered eligible for inclusion in the treatment period only if he/she has completed the run-in period and meets the following criterion. 1\. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the asthma diary and measure PEF, as directed, during the run-in period.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Most Frequent Adverse Events - On Therapy | Baseline to Week 24 | Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included. |
| Serious Adverse Events (SAEs) - On Therapy | Baseline to Week 24 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | Baseline and during Weeks 1-24 | 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. |
| Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | Baseline and during Weeks 1-24 | Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning. |
| Number of Participants With Symptom-Free Nights and Days | Baseline and Week 24 | — |
| Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 | Baseline and during Weeks 1-24 | 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. |
| Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 | Baseline and during Weeks 1-24 | 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. |
| Number of Participants With Rescue Medication-Free Nights and Days | Baseline and Week 24 | Rescue free means without the use of other medication. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Salmeterol/Fluticasone Propionate |
|---|---|
| Age, Continuous | 8.7 years STANDARD_DEVIATION 2.5 |
| Race/Ethnicity, Customized Asian | 39 participants |
| Race/Ethnicity, Customized White | 1 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / — |
| serious Total, serious adverse events | 1 / — |
Outcome results
Primary
Most Frequent Adverse Events - On Therapy
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Time frame: Baseline to Week 24
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Nasopharyngitis | 8 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Asthma | 8 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Pharyngitis | 6 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Pyrexia | 5 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Otitis media | 4 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Pharyngotonsillitis | 3 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Bronchitis | 8 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Laryngopharyngitis | 8 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Laryngotracheo bronchitis | 3 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Molluscum contagiosum | 3 Participants |
| Salmeterol/Fluticasone Propionate | Most Frequent Adverse Events - On Therapy | Stomatitis | 3 Participants |
Primary
Serious Adverse Events (SAEs) - On Therapy
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)
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Salmeterol/Fluticasone Propionate | Serious Adverse Events (SAEs) - On Therapy | 1 Participants |
Secondary
Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
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.
Time frame: Baseline and during Weeks 1-24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 | -1.62 Percent Change | Standard Deviation 3.583 |
Secondary
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
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.
Time frame: Baseline and during Weeks 1-24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 | 31.2 L/min | Standard Deviation 29.28 |
Secondary
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
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.
Time frame: Baseline and during Weeks 1-24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | 32.9 L/min | Standard Deviation 34.48 |
Secondary
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Time frame: Baseline and during Weeks 1-24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 | 12.50 Percent Change | Standard Deviation 11.294 |
Secondary
Number of Participants With Rescue Medication-Free Nights and Days
Rescue free means without the use of other medication.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Number of Participants With Rescue Medication-Free Nights and Days | Baseline | 33 Participants |
| Salmeterol/Fluticasone Propionate | Number of Participants With Rescue Medication-Free Nights and Days | Week 24 | 32 Participants |
Secondary
Number of Participants With Symptom-Free Nights and Days
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Number of Participants With Symptom-Free Nights and Days | Baseline | 29 Participants |
| Salmeterol/Fluticasone Propionate | Number of Participants With Symptom-Free Nights and Days | Week 24 | 31 Participants |