Phase 4
Completed N=300
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
Source: ClinicalTrials.gov NCT02113436 ↗Enrolled (actual)
300
Serious AEs
4.4%
Results posted
Jun 2017
Primary outcomePrimary: Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1) — -3.01; -3.97 Scores on a scale — p=0.206
◆ Published Evidence
Established
27citations · ~4 / year
The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age.
Summary
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 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.
Linked Publications
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The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1) |
-3.01; -3.97 | 0.206 |
| SECONDARY Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1) |
-1.61; -2.10 | 0.235 |
| SECONDARY Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1) |
-1.39; -1.87 | 0.236 |
| SECONDARY Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1) |
8; 4 | — |
| SECONDARY Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1) |
-0.3; 0.4 | 0.041 sig |
| SECONDARY 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; 0.01 | 0.335 |
| SECONDARY 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; -0.3 | 0.389 |
| SECONDARY Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2) |
-5.29; -6.10 | — |
Eligibility Criteria
Inclusion Criteria
- The written informed consent must be obtained from his/her parent or legally acceptable representative. If the investigator can get the oral consent from the patient, the investigator should record so in the informed consent which is signed by his/her parent or legally acceptable representative.
- Ethnic origin is Japanese
- Aged >=6 months and 200 mcg daily or equivalent) or continuous isoproterenol inhalation within 4 weeks prior to Visit 1.
Exclusion Criteria
- A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1.
- A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen.
- A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study.
- A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation.
- A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them.
- A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two).
- As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc[F])>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc>=450 msec (any correction is valid), the patient will be excluded.
- A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study.
Randomization Inclusion Criterion :
- A patient who has asthma symptoms scores (total of daytime and night-time) both over >=6 in total and >=1 per day for >=3 days at the last 7 consecutive days of the run-in period (excluding the day of Visit 2). Completion of symptom scores (daytime and night-time) on 5 or more days out of the last 7 consecutive days during the run-in period is required.
Randomization Exclusion Criteria :
- A patient who has received systemic steroids during run-in period.
- A patient who has suffered from or is suspected to have upper and lower respiratory tract infection that may affect the assessment of the efficacy during the run-in period. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available during the run-in period. Or a patient who is suspected to have RS virus infection and cannot be identified to be negative for RS virus antigen during run-in period.
- A patient who has no evaluable ECG data during the run-in period. As for the patients who has evaluable ECG data during the run-in period, QTc(F) >=450 msec. The QTc should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
- A patient who has not been able to appropriately record patient diary or inhale FP appropriately during
Data sourced from ClinicalTrials.gov (NCT02113436) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.