Phase 3
Completed N=430
A Study to Compare the Efficacy and Safety of Fluticasone Furoate (FF) 100 mcg Once Daily With Fluticasone Propionate (FP) 250 mcg Twice Daily (BD) and FP 100 mcg BD in Well-controlled Asthmatic Japanese Subjects
Source: ClinicalTrials.gov NCT02094937 ↗Enrolled (actual)
430
Serious AEs
0.3%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants (Par) Withdrawn From the Study Due to "Poorly-controlled Asthma" During Period 2 — 4.9; 7.3; 8.1 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary aim of this study is to clarify the position of FF and FF/Vilanterol (VI) 100/25 micrograms (mcg) compared with existing therapies by assessing FF dosage equivalent to low to middle-dose inhaled corticosteroids (ICS). The study is divided into Run-in period, Period 1 (open-label treatment), Period 2 (double blind treatment) and Follow-up. Subjects with well controlled asthma after completing a run-in period of 4 weeks will be switched from middle-dose ICS/long acting beta 2 agonist (LABA) equivalent dose to once-daily FF/VI 100/25 mcg for an 8 weeks treatment period (Period 1). After this, subjects will be randomized in a 1:1:1 ratio to receive either FP 250 mcg twice daily, FP 100 mcg twice daily or FF 100 mcg once daily in a 12 week double blind treatment period (Period 2). There will be a 1 week Follow-up Period following completion of the double-blind treatment period, or early withdrawal from the study. Overall , the total duration of subject's participation in the study will be for 25 weeks. RELVAR is a registered trademark of the GSK group of companies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants (Par) Withdrawn From the Study Due to "Poorly-controlled Asthma" During Period 2 |
4.9; 7.3; 8.1 | — |
| PRIMARY Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2 |
89.5; 78.2; 83.1 | — |
| SECONDARY Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2 |
-0.129; -0.135; -0.105 | — |
| SECONDARY Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2 |
-18.2; -21.3; -18.1; -19.2; -19.3; -18.7 | — |
| SECONDARY Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2 |
-1.0; -1.3; -1.8 | — |
| SECONDARY Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2 |
-0.9; -2.1; -1.2 | — |
| SECONDARY Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2 |
-0.3; -0.6; -0.8 | — |
| SECONDARY Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20) |
99.1; 97.4; 96.5 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- Type of Subject: Outpatients 18 years of age or older at Visit 1. Subjects must have a diagnosis of asthma as defined by the National Institutes of Health at least 1 year prior to Visit 1.
- Gender: Male or Eligible Female, defined as non-childbearing potential or childbearing potential using an acceptable method of birth control consistently and correctly, as defined by the following: Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; Oral contraceptive (either combined estrogen/progestin); Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Double barrier method - spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm); Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse throughout the clinical trial and for a period after the trial to account for elimination of the drug (minimum of six days); Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. A serum pregnancy test is required for females of childbearing potential at the initial screening visit (Visit 1) and Visit 11 or Early Withdrawal. In addition a urine pregnancy test will be performed on all females of childbearing potential at Visit 2, Visit 5 and Visit 12.
- Severity of Disease: A best pre-bronchodilator FEV1 of >=80% of the predicted normal value at the screening visit (Visit 1). Predicted values will be based upon National Health and Nutrition Examination Survey (NHANES) III. As subjects are Asian, the Asian adjustment will be used.
- Stable Asthma: Subjects must have stable asthma, as judged by the Investigator. This includes no change in asthma medication for at least 8 weeks prior to Visit 1 and an ACT score of >=20 at Visit 1.
- Current Anti-Asthma Therapy: All subjects must be using the middle-dose ICS/LABA which is equivalent to twice-daily combination of fluticasone propionate and salmeterol 250 mcg for at least 12 weeks prior to the registration visit. In addition, the prescription of the middle-dose ICS/LABA shouldn't be changed at least 8 weeks prior to Visit 1.
- Short-Acting Beta2-Agonists (SABA): All subjects must be able to use salbutamol aerosol inhaler which will be provided as a rescue medication at Visit 1 during the study as needed. Subjects must be able to avoid using salbutamol for at least 6 hours prior to study visits.
- 12-lead electrocardiogram (ECG): Evidence of significant normality in the 12-lead ECG performed at Visit 1, as judged by the investigator Selected specific ECG findings that are not considered to be significant and will not exclude the subject from study participation include, but are not limited to, the following: T interval corrected for heart rate (QTc) =80%
- Compliance with completion of both morning and evening eDairy data fulfils >=5days in one week prior to Visit 2 and Visit 5.
Exclusion Criteria
- History of Life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 10 years.
- Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 8 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
- Asthma Exacerbation: Any asthma exacerbation requiring systemic corticosteroids or injection within 12 weeks of Visit 1 or that resulted in overnight hospitalization requiring additional treatment
Data sourced from ClinicalTrials.gov (NCT02094937). 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.