Phase 3
Completed N=82
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma
Source: ClinicalTrials.gov NCT01978119 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85 — 0.231; 0.203 Liter
Summary
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 week non inferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and FSC 250/50 mcg multi-dose inhaler each administered BID in adults and adolescents with asthma. The primary objective of this study is to demonstrate that FSC 250/50 mcg administered BID by capsule-based inhaler is non-inferior compared to FSC 250/50 mcg administered BID by multi-dose inhaler . The study consists of six phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 3 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 31 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85 |
0.231; 0.203 | — |
| SECONDARY FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period |
27.642; 27.995 | — |
| SECONDARY FEV1 AUC (0-12) at Day 85 of Each Treatment Period |
28.317; 28.039 | — |
| SECONDARY Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56 |
0.245; 0.238; 0.224; 0.202 | — |
| SECONDARY Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP) |
23.02; 18.67 | — |
| SECONDARY Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP) |
-0.41; -0.36 | — |
| SECONDARY Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP) |
-0.38; -0.25; -0.16; -0.14 | — |
| SECONDARY Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks |
11.36; 13.61 | — |
| SECONDARY Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period |
3.0; 3.2 | — |
| SECONDARY Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP) |
6.04; 6.81 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female >=12 and 40 milli international unit per milliliter (mIU/mL) and oestradiol =40% to =12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes after 2 to 4 inhalations of salbutamol inhalation aerosol (or equivalent nebulised treatment with salbutamol solution) at Visit 1 (Screening and Run-in Visit).
- Current anti-asthma therapy: All subjects must be using an Inhaled Corticosteroid (ICS) with or without long-acting beta-adrenergic agonist (LABA) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). Two populations are eligible for enrolment: - Subjects maintained on ICS monotherapy (FP 100 mcg to 250 mcg BID or equivalent) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit) or Subjects maintained on an ICS/LABA combination product (e.g., Fluticasone propionate/salmeterol 100/50 or 250/50 mcg BID or equivalent by other combination products or by separate inhalers) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). Subjects taking budesonide/formoterol or beclomethasone/formoterol as needed must switch to budesonide/formoterol maintenance dosing (excluding the highest dose) with use of a SABA for symptom relief at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). NOTE: Subjects on low dose ICS monotherapy should only be enrolled, if, in the opinion of the investigator, after review of their medical history and clinical examination, they will be able to benefit from both an increase in ICS dose and the addition of LABA therapy arising from and ICS/LABA combination.
- Ability to withhold LABA therapy: Other than what is provided during the study, LABA therapy is not permitted on the day of Visit 1 (Screening and Run-in Visit) and throughout the entire study. The last dose of LABA and LABA/ICS combinations are to be taken on the day before Visit 1. Sites should contact the medical monitor to discuss subject eligibility, for doses of commonly prescribed ICS and ICS/LABA combination medication; as mentioned in the study protocol.
- SABA: All subjects must be able to replace their current SABA treatment with rescue salbutamol/albuterol at Visit 1 (Screening and Run-in Visit) for use as needed for the duration of the study. Subjects must be able to withhold salbutamol/albuterol for at least 6 hours before each study visit.
- Liver safety criteria: Alanine aminotransferase (ALT) 1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) at Visit 1 (Screening and Run-in Visit).
- Electrocardiogram (ECG) safety criteria: The subject must have no ECG abnormalities that would, in the opinion of investigator, compromise subject safety, or significantly affect subject's ability to complete the trial. As such, the investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. At Visit 1 (Screening and Run-in Visit), ECG safety criteria must be: QT interval corrected for heart rate (QTc) or QT interval corrected for heart rate according to Fridericia formula (QTcF) <450 msec or QTc <480 msec for subjects with bundle branch block; Investigators will be responsible for ensuring appropriate clinical interpretation of ECGs.
- The subject and/or the subject's legal guardian (if applicable) must be capable of giving informed consent/assent, which includes compliance with the study requirements and restrictions listed in the consent/assent form.
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
Data sourced from ClinicalTrials.gov (NCT01978119). 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.