Trial Outcomes & Findings for Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis (NCT NCT00118703)

Last Updated: 2017-08-21

Results Overview

The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \[PM\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

350 participants

Primary outcome timeframe

Baseline and up to Week 4

Results posted on

2017-08-21

Participant Flow

The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.

Males and females \>=12 years of age, diagnosed with vasomotor rhinitis (VMR) and meeting the symptom requirements entered a 7 to 14 days screening period. Following screening period, participants meeting specified symptom criteria received treatment of either fluticasone furoate or placebo in 1:1 ratio up to 4 weeks.

Participant milestones

Participant milestones
Measure	Placebo Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian \[AM\]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Overall Study STARTED	173	174
Overall Study COMPLETED	168	165
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were instructed to self administer two sprays of placebo into each nostril once daily (QD) in the morning (ante meridian \[AM\]), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Overall Study Protocol Violation	1	0
Overall Study Adverse Event	1	1
Overall Study Participant took two different treatment	0	1
Overall Study Withdrawal by Subject	2	5
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Vasomotor Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=173 Participants Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=174 Participants Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Total n=347 Participants Total of all reporting groups
Age, Continuous	44 Years STANDARD_DEVIATION 14.72 • n=5 Participants	43.8 Years STANDARD_DEVIATION 15.44 • n=7 Participants	43.9 Years STANDARD_DEVIATION 15.06 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	124 Participants n=7 Participants	232 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	50 Participants n=7 Participants	115 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	164 Participants n=5 Participants	167 Participants n=7 Participants	331 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to Week 4

Population: Intent-to-Treat (ITT) population comprised of all participants who were randomized and received at least one dose of study drug. Only participants present at the specified time point were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=172 Participants Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Mean Change From Baseline in Daily Reflective Total Nasal Symptom Scores (rTNSS)	-2.11 Score on a scale Standard Error 0.15	-2.01 Score on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline and up to Week 4

Population: ITT population. Only participants available at the specified timepoint were analyzed.

The morning pre-dose iTNSS was the sum of the individual symptom score for rhinorrhoea, nasal congestion and postnasal drip performed immediately prior to taking the daily dose which were scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The Baseline daily iTNSS was defined as the average of the daily iTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=172 Participants Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Mean Change From Baseline in Morning (AM) Pre-dose Instantaneous Total Nasal Symptom Scores (iTNSS)	-1.65 Score on a scale Standard Error 0.14	-1.59 Score on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: Week 4 (Day 29) or Early Withdrawal

Population: ITT Population. Only participants available at the specified time point were analyzed.

Participants were evaluated effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period. The overall evaluation of response to therapy was based on a 7-point categorical scale (1-7) where the participants rate their perception of the change or lack of change in their VMR symptoms at the end of the study. The 7 categories were: 1: significantly improved, 2: moderately improved, 3: mildly improved, 4: no change, 5: mildly worse, 6: moderately worse and 7: significantly worse. Effectiveness of study medication for relieving VMR symptoms over the entire treatment period.

Outcome measures

Outcome measures
Measure	Placebo n=172 Participants Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=171 Participants Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Number of Participants Based on Overall Evaluation of Response to Therapy Significantly Improved	20 Participants	28 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy Moderately Improved	39 Participants	41 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy Mildly Improved	42 Participants	43 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy No Change	63 Participants	50 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy Mildly Worse	3 Participants	4 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy Moderately Worse	2 Participants	3 Participants
Number of Participants Based on Overall Evaluation of Response to Therapy Significantly Worse	3 Participants	2 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Fluticasone Furoate 110 µg QD

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=173 participants at risk Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=174 participants at risk Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	0.57% 1/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.

Other adverse events

Other adverse events
Measure	Placebo n=173 participants at risk Participants were instructed to self administer two sprays of placebo into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.	Fluticasone Furoate 110 µg QD n=174 participants at risk Participants were instructed to self administer two sprays of fluticasone furoate 110 µg into each nostril QD in the morning (AM), following pre-dose symptom assessment. Administration of the dose was performed by alternately spraying one spray to each nostril followed by a second spray to each nostril.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 5/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	6.9% 12/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.9% 5/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	2.3% 4/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Nervous system disorders Headache	9.2% 16/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	8.0% 14/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Gastrointestinal disorders Diarrhoea	0.00% 0/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	2.3% 4/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Musculoskeletal and connective tissue disorders Back pain	2.3% 4/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	0.57% 1/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Infections and infestations Nasopharyngitis	5.8% 10/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	6.3% 11/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.
Infections and infestations Upper respiratory tract infection	2.3% 4/173 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.	0.57% 1/174 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from on or after the randomization date (Up to Day 34). ITT Population was used.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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