Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis (NCT NCT01231464)

Last Updated: 2017-07-06

Results Overview

The Total Nasal Symptom Score (TNSS; possible score of 0-12) is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS was performed in the morning (AM rTNSS) and evening (PM rTNSS) and assessed the participant's symptoms over the preceding 12 hours. The daily rTNSS is the average of the AM rTNSS and PM rTNSS assessments. Mean changes from baseline over the entire treatment period were calculated as treatment period rTNSS minus baseline rTNSS.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

365 participants

Primary outcome timeframe

Baseline through entire treatment period (Day 1 through Day 14)

Results posted on

2017-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	FFNS 110 mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo Matching Vehicle Placebo Nasal Spray QD
Overall Study STARTED	182	183
Overall Study COMPLETED	177	176
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	FFNS 110 mcg Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo Matching Vehicle Placebo Nasal Spray QD
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	1	2
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FFNS 110 mcg n=181 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo n=182 Participants Matching Vehicle Placebo Nasal Spray QD	Total n=363 Participants Total of all reporting groups
Age, Continuous	31.8 Years STANDARD_DEVIATION 10.72 • n=5 Participants	33.0 Years STANDARD_DEVIATION 10.95 • n=7 Participants	32.4 Years STANDARD_DEVIATION 10.84 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	99 Participants n=7 Participants	196 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants	83 Participants n=7 Participants	167 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	181 participants n=5 Participants	182 participants n=7 Participants	363 participants n=5 Participants
Race/Ethnicity, Customized Not Chinese	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline through entire treatment period (Day 1 through Day 14)

Population: Full Analysis Set (FAS): all participants who were randomized and received at least one dose of study medication. Only participants for whom both baseline and post-baseline data were available were included in this analysis.

Outcome measures

Outcome measures
Measure	FFNS 110 mcg n=179 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo n=178 Participants Matching Vehicle Placebo Nasal Spray QD
Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Total Nasal Symptom Score (rTNSS)	-4.226 Points on a scale Standard Error 0.1646	-2.728 Points on a scale Standard Error 0.1656

SECONDARY outcome

Timeframe: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)

Population: FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.

The nasal finding score by rhinoscopy (possible score of 0-12) is the sum of 4 individual investigator assessed scores for swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume, and description of rhinorrhea. The symptoms were assessed using a scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. Mean change from baseline to the end of study in nasal finding score by rhinoscopy was calculated as the nasal finding score by rhinoscopy at Visit 4/Early Withdrawal minus the nasal final finding score by rhinoscopy at Visit 2.

Outcome measures

Outcome measures
Measure	FFNS 110 mcg n=176 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo n=177 Participants Matching Vehicle Placebo Nasal Spray QD
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Nasal Finding Score by Rhinoscopy	-4.2 Points on a scale Standard Error 0.22	-2.9 Points on a scale Standard Error 0.22

SECONDARY outcome

Timeframe: Baseline through end of study (Day 1 through Day 15/Early Withdrawal)

Population: FAS Population. Only participants for whom both baseline and post-baseline data were available were included in the analysis.

The severity of overall interference in activities of daily living at baseline and the end of study was assessed by the investigator on the scale of 0=None, 1=Mild, 2=Moderate, 3=Severe. The mean change from baseline to the end of study in severity of overall interference in activities of daily living was calculated as the severity of overall interference in activities of daily living at Visit 4/Early Withdrawal minus severity of overall interference in activities of daily living at Visit 2.

Outcome measures

Outcome measures
Measure	FFNS 110 mcg n=160 Participants Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo n=165 Participants Matching Vehicle Placebo Nasal Spray QD
Mean Change From Baseline (Visit 2) to the End of Study (Visit 4/Early Withdrawal) in Severity of Overall Interference in Activities of Daily Living	-1.2 Points on a scale Standard Error 0.07	-0.8 Points on a scale Standard Error 0.07

Adverse Events

FFNS 110 mcg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	FFNS 110 mcg n=181 participants at risk Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)	Placebo n=182 participants at risk Matching Vehicle Placebo Nasal Spray QD
Infections and infestations Upper respiratory tract infection	2.2% 4/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	1.1% 2/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	1.6% 3/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Infections and infestations Oral herpes	0.55% 1/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 2/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.1% 2/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.55% 1/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinalgia	1.1% 2/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Sputum	0.55% 1/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Gastrointestinal disorders Nausea	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Dizziness	1.1% 2/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Nervous system disorders Headache	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Investigations Blood urine present	0.00% 0/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.55% 1/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.55% 1/181 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.	0.00% 0/182 Serious and non-serious adverse events were collected in the Safety Set, comprised of all participants who were randomized and received at least one dose of study medication.