Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine | NCT00502775

Name	Type	Description	Arm Group Labels	Other Names
fluticasone furoate, fexofenadine	Drug			fluticasone furoate fexofenadine

Measure	Description	Time Frame
Mean Change From Baseline in the Nighttime Symptom Score (NSS)	Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.	Baseline and Weeks 1-2

Measure	Description	Time Frame
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)	Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Informed consent
Otherwise healthy outpatient with mountain cedar allergy
Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
Age 12 years or older at Visit 2
Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
Adequate exposure to mountain cedar pollen
Ability to comply with study procedures
Literate

Exclusion criteria:

Significant concomitant medical conditions
Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
Use of other allergy medications within specific timeframes relative to Visit 1
Use of other medications that may affect allergic rhinitis or its symptoms
Use of immunosuppressive medications eight weeks prior to screening and during the study
Immunotherapy patients who are not stable on current dose
Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
Use of contact lenses
Recent clinical trial/experimental medication experience within 30 days of Visit 1
Subject previously failed the 21-day screen period or failed to complete the treatment period
Positive or inconclusive pregnancy test or female who is breastfeeding
Employee or relative affiliation with investigational site
Current tobacco use
Active chickenpox or measles or exposure in the last 3 weeks

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Little Rock	Arkansas	72205	United States
GSK Investigational Site

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
FFU109047	Clinical Study Report	View IPD

ID	Title	Description
FG000	Placebo
FG001	Fluticasone Furoate 110mcg
FG002	Fexofenadine 180 mg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.

One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000228 OG001224 OG002226

Title

Denominators

Categories

Title	Measurements
	OG000-2.3± 0.11 OG001-3.1± 0.12 OG002-2.2± 0.12

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.	ANCOVA	No other strata or covariates, other than investigator, were defined.	<0.001	Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.	Mean Difference (Net)	-0.9	Standard Error of the Mean	0.16		95	-1.2	-0.6

Secondary

Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)

Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)

Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)

Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)

Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)

Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)

Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.

Two subjects in the placebo group & three in the FFNS group recorded no data during the two-week treatment period.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)

Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.

Two subjects in the placebo group & two in the FFNS group recorded no data during the two-week treatment period.

Posted

Mean

Standard Error

Score on a Scale

Baseline and Weeks 1-2

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants	OG000

Secondary

Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.

Ten placebo subjects, six FFNS subjects, and four fexofenadine subjects had no overall NRQLQ score at endpoint, indicating either a missing score for one or more of the NRQLQ domains, a missing baseline score, or both. One additional FFNS patient had no on-treatment NRQLQ data.

Posted

Mean

Standard Error

Score on a Scale

Baseline, Day 15 or if Early Withdrawal Day

ID	Title	Description
OG000	Placebo
OG001	Fluticasone Furoate 110mcg
OG002	Fexofenadine 180 mg

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Headache	Nervous system disorders	MedDRA	EG0006 affected229 at risk EG00110 affected224 at risk EG0029 affected227 at risk
Sinus headache	Nervous system disorders	MedDRA	EG0001 affected229 at risk EG0011 affected224 at risk EG0021 affected227 at risk
Dizziness	Nervous system disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0021 affected227 at risk
Tension headache	Nervous system disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Migraine	Nervous system disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Somnolence	Nervous system disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0013 affected224 at risk EG0023 affected227 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0002 affected229 at risk EG0010 affected224 at risk EG0024 affected227 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0012 affected224 at risk EG0022 affected227 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0021 affected227 at risk
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Nasal septum disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Nasal septum ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	EG0002 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Rhinitis	Infections and infestations	MedDRA	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Sinusitis	Infections and infestations	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Gastroenteritis	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Lymph gland infection	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Oral fungal infection	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Otitis media	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Respiratory tract infection	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Staphylococcal infection	Infections and infestations	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Urinary tract infection	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Viral infection	Infections and infestations	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0021 affected227 at risk
Nausea	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0021 affected227 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Chapped lips	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Lip swelling	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Oral pain	Gastrointestinal disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	EG0000 affected229 at risk EG0012 affected224 at risk EG0022 affected227 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Human bite	Injury, poisoning and procedural complications	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Fatigue	General disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Feeling jittery	General disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Ill-defined disorder	General disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	EG0001 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk
Conjunctivitis	Eye disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Eyelid oedema	Eye disorders	MedDRA	EG0001 affected229 at risk EG0010 affected224 at risk EG0020 affected227 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	EG0000 affected229 at risk EG0010 affected224 at risk EG0021 affected227 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA	EG0000 affected229 at risk EG0011 affected224 at risk EG0020 affected227 at risk

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D065631	Rhinitis, Allergic

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity
D010038	Otorhinolaryngologic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo
BG001	Fluticasone Furoate 110mcg
BG002	Fexofenadine 180 mg
BG003	Total	Total of all reporting groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	0	229	27	229
EG001	Fluticasone Furoate 110mcg	0	224	31	224
EG002	Fexofenadine 180 mg	1	227	37	227