Trial Outcomes & Findings for RELOVAIR® Lung Deflation Study (NCT NCT01691885)
NCT ID: NCT01691885
Last Updated: 2016-10-27
Results Overview
RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.
COMPLETED
PHASE3
45 participants
Baseline and end of Treatment Period (7 days)
2016-10-27
Participant Flow
At Visit 1a, participants who met the eligibility criteria stopped their respiratory medication in preparation for their lung volume assessment at screening Visit 1b. At Visit 1b, participants entered a 7(plus or minus 3) day Run-in Period. Overall study duration, following Screening to Follow-up, was 36 days up to a maximum of 54 days.
Participant milestones
| Measure |
Placebo Then FF/VI
Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
|
FF/VI Then Placebo
Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
|
|---|---|---|
|
Treatment Period 1(7-14 Days)
STARTED
|
22
|
23
|
|
Treatment Period 1(7-14 Days)
COMPLETED
|
21
|
22
|
|
Treatment Period 1(7-14 Days)
NOT COMPLETED
|
1
|
1
|
|
Washout Period (7-9 Days)
STARTED
|
21
|
22
|
|
Washout Period (7-9 Days)
COMPLETED
|
21
|
21
|
|
Washout Period (7-9 Days)
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2 (7-14 Days)
STARTED
|
21
|
21
|
|
Treatment Period 2 (7-14 Days)
COMPLETED
|
21
|
21
|
|
Treatment Period 2 (7-14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Then FF/VI
Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
|
FF/VI Then Placebo
Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
|
|---|---|---|
|
Treatment Period 1(7-14 Days)
Adverse Event
|
1
|
1
|
|
Washout Period (7-9 Days)
Adverse Event
|
0
|
1
|
Baseline Characteristics
RELOVAIR® Lung Deflation Study
Baseline characteristics by cohort
| Measure |
Per Protocol Population
n=45 Participants
All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
|
|---|---|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of Treatment Period (7 days)Population: PP Population. Only those participants available at the specified time points were analyzed
RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.
Outcome measures
| Measure |
Placebo
n=41 Participants
Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
|
FF/VI
n=43 Participants
Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
|
|---|---|---|
|
Mean Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVI) at the End of the Overall Treatment Period
|
-0.47 Milliliter per meter square (mL/m^2)
Standard Error 1.393
|
5.35 Milliliter per meter square (mL/m^2)
Standard Error 1.365
|
Adverse Events
Placebo
FF/VI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=43 participants at risk
Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
|
FF/VI
n=44 participants at risk
Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
|
|---|---|---|
|
Nervous system disorders
Headache
|
4.7%
2/43 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to the end of treatment (Study Day 23)
|
4.5%
2/44 • On treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study treatment and up to the end of treatment (Study Day 23)
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER