A Phase 4 interventional study of FP/ SLM HFA MDI 50/25 mcg and FP HFA MDI 50 mcg in Asthma, sponsored by GlaxoSmithKline. Completed at 69 sites in Japan. Open to participants aged 6 Months to 4 Years. Per ClinicalTrials.gov, last updated 2017-06-16.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period. The study is designed to evaluate the efficacy and safety of FP/ SLM HFA MDI 50/25 microgram (mcg) one or two inhalation twice daily (BID) for 8 weeks in comparison with FP HFA MDI 50 mcg one or two inhalation BID, in 6-month to 4-year-old Japanese patients with bronchial asthma. The study is also designed to evaluate the safety of long-term treatment of FP/ SLM HFA MDI 50/25 mcg one or two BID for 16 weeks.
The subjects meeting the eligibility criteria will enter the run-in period of 2 weeks and receive FP 50 mcg 1 or 2 inhalation bid (FP 100 or 200 mcg/day), before randomization. The subjects under 2 years of age at Visit 1 will receive only 1 inhalation bid during the run-in period. The subjects who meet the eligibility criteria for randomization will be stratified according to their age (\<2 or >=2 year-old) at Visit 1 and randomized to one of the two treatment groups.
The total duration of participation in the study will be 10 weeks for a comparison period completion and 27 weeks for a completion.
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Exclusion Criteria:
Randomization Inclusion Criterion :
Randomization Exclusion Criteria :
Subject will receive 1 or 2 inhalation of SLM 25mcg plus FP 50mcg twice daily in the first treatment period for 8 weeks and will continue to receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period.
Drug: FP/ SLM HFA MDI 50/25 mcg
Subject will receive 1 or 2 inhalation of FP 50mcg twice daily in the first treatment period for 8 weeks and will receive SLM 25mcg plus FP 50mcg one or two inhalation twice daily for 16 weeks in the second treatment period.
Drug: FP/ SLM HFA MDI 50/25 mcg · Drug: FP HFA MDI 50 mcg
Metered-dose aerosol product containing 50 mcg of fluticasone propionate and 25 mcg of salmeterol per inhalation
Metered-dose aerosol product containing 50 mcg of fluticasone propionate per inhalation
Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1)
The participant's parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 6 per day. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
Time frame: Baseline and Week 8
Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1)
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
Time frame: Baseline and Week 8
Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1)
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
Time frame: Baseline and Week 8
Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1)
The definition of exacerbations was amended during the study. \<Original\> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. \<Amendment\> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.
Time frame: Up to 8 weeks
Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1)
Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
Time frame: Baseline and Week 8
Mean Change From Baseline in Use of Rescue Medication (Number of Occasions Used During a 24-hour Period) in Treatment Period 1 (TP1)
The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
Time frame: Baseline and Week 8
Mean Change From Baseline in Use of Rescue Medication (Percentage of Days With Rescue-free 24-hour Period) at the End of Treatment Period 1 (TP1)
The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
Time frame: Baseline and Week 8
Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2)
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant in a patient diary twice daily (daytime and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP2 (Week 24). Scores ranged from 0 (none) to 3 (severe) and maximum score is 6 per day. Change from Baseline in the asthma symptom scores at daytime plus night time at the end of TP2 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]).The end of the TP2 value is a mean value of the last 7 consecutive days during the TP2 (excluding the last day of the TP2). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who received at least one dose of open-label medication in the TP2 were analyzed.
Time frame: Baseline and Week 24
Study evaluated the efficacy and safety of fluticasone propionate (FP)/salmeterol xinafoate hydrofluoroalkane (SLM HFA) twice-daily (BID) via metered-dose inhaler (MDI) for 8 weeks in comparison with FP HFA in 6-months to 4-years-old Japanese participants (par.) with infantile bronchial asthma.
| Milestone | FP HFA 50 µg | FP/SLM HFA 50/25 µg | FP HFA 50 µg - FP/SLM HFA 50/25 µg | FP/SLM 50/25 µg - FP/SLM 50/25 µg |
|---|---|---|---|---|
| Started | 150 | 150 | 0 | 0 |
| Completed | 142 | 148 | 0 | 0 |
| Not completed | 8 | 2 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 |
| Withdrew: Par. reached stopping criteria | 5 | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 |
| Milestone | FP HFA 50 µg | FP/SLM HFA 50/25 µg | FP HFA 50 µg - FP/SLM HFA 50/25 µg | FP/SLM 50/25 µg - FP/SLM 50/25 µg |
|---|---|---|---|---|
| Started | 0 | 0 | 141 | 147 |
| Completed | 0 | 0 | 132 | 136 |
| Not completed | 0 | 0 | 9 | 11 |
| Withdrew: Adverse event | 0 | 0 | 4 | 5 |
| Withdrew: Par. reached stopping criteria | 0 | 0 | 2 | 5 |
| Withdrew: Physician decision | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 1 |
The participant's parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 6 per day. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
| Scores on a scale | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1) | -3.01 ± 0.545 | -3.97 ± 0.534 |
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
| Scores on a scale | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1) | -1.61 ± 0.292 | -2.10 ± 0.286 |
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
| Scores on a scale | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1) | -1.39 ± 0.287 | -1.87 ± 0.281 |
The definition of exacerbations was amended during the study. \<Original\> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. \<Amendment\> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.
| Participants | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1) | 8 | 4 |
Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.
| Scores on a scale | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1) | -0.3 ± 0.25 | 0.4 ± 0.24 |
The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
| Occasions per 24 hours | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Use of Rescue Medication (Number of Occasions Used During a 24-hour Period) in Treatment Period 1 (TP1) | 0.07 ± 0.048 | 0.01 ± 0.047 |
The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.
| Percentage of days | FP HFA 50 µg | FP/SLM HFA 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Use of Rescue Medication (Percentage of Days With Rescue-free 24-hour Period) at the End of Treatment Period 1 (TP1) | -2.9 ± 2.16 | -0.3 ± 2.11 |
The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant in a patient diary twice daily (daytime and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP2 (Week 24). Scores ranged from 0 (none) to 3 (severe) and maximum score is 6 per day. Change from Baseline in the asthma symptom scores at daytime plus night time at the end of TP2 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 \[Randomization\]).The end of the TP2 value is a mean value of the last 7 consecutive days during the TP2 (excluding the last day of the TP2). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who received at least one dose of open-label medication in the TP2 were analyzed.
| Scores on a scale | FP 50 µg - FP/SLM 50/25 µg | FP/SLM 50/25 µg - FP/SLM 50/25 µg |
|---|---|---|
| Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2) | -5.29 ± 6.422 | -6.10 ± 7.665 |
Collected over All on-treatment serious adverse events (SAEs) and non-serious AEs were collected for 25 weeks in Treatment Period 1 and Treatment Period 2. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Period 1 - FP HFA 50 µg | — | 5/150 (3.3%) | 109/150 (72.7%) |
| Period 1 - FP/SLM HFA 50/25 µg | — | 1/150 (0.7%) | 111/150 (74%) |
| Period 2 - FP/SLM HFA 50/25 μg | — | 20/288 (6.9%) | 262/288 (91%) |
| Event | Period 1 - FP HFA 50 µg | Period 1 - FP/SLM HFA 50/25 µg | Period 2 - FP/SLM HFA 50/25 μg |
|---|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/150 | 0/150 | 8/288 |
| PneumoniaInfections and infestations | 0/150 | 0/150 | 7/288 |
| BronchitisInfections and infestations | 0/150 | 1/150 | 1/288 |
| GastroenteritisInfections and infestations | 1/150 | 0/150 | 1/288 |
| Upper respiratory tract infectionInfections and infestations | 1/150 | 0/150 | 0/288 |
| HerpanginaInfections and infestations | 0/150 | 0/150 | 1/288 |
| Otitis media acuteInfections and infestations | 0/150 | 0/150 | 1/288 |
| Pneumonia bacterialInfections and infestations | 0/150 | 0/150 | 1/288 |
| PseudocroupInfections and infestations | 0/150 | 0/150 | 1/288 |
| Tracheobronchitis mycoplasmalInfections and infestations | 0/150 | 0/150 | 1/288 |
| Event | Period 1 - FP HFA 50 µg | Period 1 - FP/SLM HFA 50/25 µg | Period 2 - FP/SLM HFA 50/25 μg |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 24/150 | 18/150 | 68/288 |
| Upper respiratory tract infectionInfections and infestations | 17/150 | 28/150 | 56/288 |
| GastroenteritisInfections and infestations | 13/150 | 11/150 | 43/288 |
| BronchitisInfections and infestations | 13/150 | 14/150 | 42/288 |
| PharyngitisInfections and infestations | 9/150 | 11/150 | 39/288 |
| InfluenzaInfections and infestations | 4/150 | 3/150 | 38/288 |
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 18/150 | 10/150 | 34/288 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 10/150 | 4/150 | 27/288 |
| SinusitisInfections and infestations | 4/150 | 3/150 | 20/288 |
| Hand-foot-and-mouth diseaseInfections and infestations | 4/150 | 9/150 | 9/288 |
| Age, Continuous(Months) | FP HFA 50 µg | FP/SLM HFA 50/25 µg | Total |
|---|---|---|---|
| Overall Study | 38.4 ± 14.10 | 40.5 ± 14.07 | 39.5 ± 14.11 |
| Sex: Female, Male(Participants) | FP HFA 50 µg | FP/SLM HFA 50/25 µg | Total |
|---|---|---|---|
| Female | 60 | 55 | 115 |
| Male | 90 | 95 | 185 |
| Race/Ethnicity, Customized(Participants) | FP HFA 50 µg | FP/SLM HFA 50/25 µg | Total |
|---|---|---|---|
| Asian - Japanese Heritage | 150 | 150 | 300 |
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