Phase 3
Completed N=426
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Fluticasone Propionate/Salmeterol (FSC) 250/50 Microgram (mcg) Through a Capsule-Based Inhaler and a Multi-Dose Inhaler Administered Twice Daily (BID) in Adults With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01978145 ↗
Enrolled (actual)
426
Serious AEs
2.7%
Results posted
Jan 2016
Primary outcomePrimary: Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85 — 0.116; 0.091 Liters (L)
Summary
This is a multi-centre, randomised, double-blind, double-dummy, two way cross-over, 12 weeks noninferiority study to evaluate the efficacy, safety, and tolerability of FSC 250/50 mcg capsule-based inhaler and a multi-dose inhaler administered BID in adults with COPD. The primary objective of this study is to establish the non-inferiority of the efficacy of the FSC 250/50 mcg capsule-based inhaler compared to the FSC 250/50 mcg multi-dose inhaler administered BID. The study consists of 6 phases: Pre-screening, Screening/Run-in (3 weeks), Treatment Period 1 (12 weeks), Washout (minimum 4 weeks), Treatment Period 2 (12 weeks) and Follow-up (1 week). The total duration of the study for each subject will be at least 32 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85 |
0.116; 0.091 | — |
| SECONDARY Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 28 and 56 |
0.108; 0.104; 0.135; 0.115 | — |
| SECONDARY FEV1 Area Under the Curve From 0 to 10 Hours (AUC [0-10]) on Day 85 of Each Treatment Period |
13.382; 13.216 | — |
| SECONDARY Change From Baseline in Transition Dyspnoea Index (TDI) Focal Score at Days 28, 56 and 85 |
1.982; 1.984; 1.968; 2.037; 1.941; 2.074 | — |
| SECONDARY Change From Baseline in St George's Respiratory Questionnaire-COPD (SGRQ C) Score at Week 12 |
-3.48; -3.72 | — |
| SECONDARY Change From Baseline in COPD Assessment Test (CAT) Scores at Week 12 |
-2.3; -1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female >=40 and 40 milli international unit per milliliter (mIU/mL) and oestradiol =30% of predicted normal values at Visit 1 (Screening and Run-in Visit). Predicted values will be calculated using the National Health and Nutrition Examination Survey (NHANES) III reference equations.
- Tobacco Use: Current or prior history of at least 10 pack-years of cigarette smoking (e.g., 20 cigarettes/day for 10 years). One pack-year is defined as 20 manufactured cigarettes (1 pack) smoked per day for 1 year. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 (Screening and Run-in Visit). Former smokers are eligible to enter the study provided they have at least 10 pack-years smoking history. Subjects making a conscious decision to stop smoking at any time during the study and who refrain from smoking for >4 weeks will be discontinued from the study. Additionally, subjects who start smoking during the study and smoke for at least 7 consecutive days will be discontinued from the study.
- Dyspnoea: A score of >=2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1 (Screening and Run-in Visit)
- Liver Safety Criteria: Alanine aminotransferase (ALT) 1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is 5000 feet) provided subject does not require a flow rate of >2 L/minute Use for exertion provided subject does not require >2 hours per day of oxygen and does not require a flow rate of >2 L/minute Use for nocturnal therapy provided subject does not require a flow rate of >2 L/minute
- Pregnant females as determined by urine test at Visit 1(Screening and Run-in Visit) or prior to dosing. A confirmatory serum pregnancy test is required if the urine test is questionable or positive
- Lactating females
- A known history of a positive hepatitis B surface antigen or a positive hepatitis C.
- Unable to comply with study procedures
Data sourced from ClinicalTrials.gov (NCT01978145). 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.