Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02397915
• Date of registration: 19/03/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
• Scientific title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Mometasone Furoate Nasal Spray in Subjects With Allergic Rhinitis
• Date of first enrolment: March 26, 2015
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02397915
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Korea, Republic of, Russian Federation

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects who are between 18 to 65 years of age, inclusive at the time
of signing the informed consent.

- Severity of disease: Subjects who meet the below criteria and who may also have
vasomotor rhinitis are eligible for the study. A positive skin test to perennial (for
example, but not limited to, animal dander, house dust mites, cockroach, mould) and /
or seasonal (for example, but not limited to, grass, tree, weed, ragweed) allergen
within 12 months prior to Screening. If a subject has not been tested in the 12 months
prior to Screening, a positive skin test (by prick method) is required at Screening. A
positive skin test is defined as a wheal >=3 millimeters (mm) larger than the diluent
control for prick testing. In vitro tests for specific Immunoglobulin E (IgE) [such as
radioallergosorbent test (RAST), paper radioimmunosorbent test (PRIST)] will not be
allowed as a diagnosis of AR.

- A female subject is eligible to participate if she is not pregnant [as confirmed by a
negative urine (preferred) or serum human chorionic gonadotrophin (hCG) test], not
lactating, and at least one of the following conditions applies: (a) Non-reproductive
potential defined as premenopausal females with a documented tubal ligation or
documented hysteroscopic tubal occlusion procedure with follow-up confirmation of
bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone
replacement therapy (HRT) and whose menopausal status is in doubt will be required to
use one of the highly effective contraception methods if they wish to continue their
HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of
post-menopausal status prior to study enrolment. (b) Reproductive potential and agrees
to follow one of the options listed below in the GlaxoSmithKline (GSK) modified list
of highly effective methods for avoiding pregnancy in females of reproductive
potential (FRP) requirements from 30 days prior to the first dose of study medication
and until at least 4 days after the last dose of study medication. The GSK modified
list of highly effective methods includes: contraceptive subdermal implant that meets
the standard operating procedure (SOP) effectiveness criteria including a <1% rate of
failure per year, as stated in the product label; Intrauterine device or intrauterine
system that meets the SOP effectiveness criteria including a <1% rate of failure per
year, as stated in the product label; Oral contraceptive; either combined or
progestogen alone; Injectable progestogen; Contraceptive vaginal ring; Percutaneous
contraceptive patches; Male partner sterilization with documentation of azoospermia
prior to the female subject's entry into the study, and this male is the sole partner
for that subject. This list does not apply to FRP with same sex partners, when this is
their preferred and usual lifestyle or for subjects who are and will continue to be
abstinent from penile-vaginal intercourse on a long term and persistent basis.

- A male subject is eligible to participate if (a) subjects with female partners of
child bearing potential comply with the following contraception requirements from the
time of first dose of study medication until at least 4 days after the last dose of
study medication; (b) Vasectomy with documentation of azoospermia; (c) Male condom
plus partner use of one of the contraceptive options: Contraceptive subdermal implant
that meets the SOP effectiveness criteria including a <1% rate of failure per year, as
stated in the product label; Intrauterine device or intrauterine system that meets the
SOP effectiveness criteria including a <1% rate of failure per year, as stated in the
product label; Oral contraceptive, either combined or progestogen alone, Injectable
progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches. These
allowed methods of contraception are only effective when used consistently, correctly
and in accordance with the product label. The investigator is responsible for ensuring
that subjects understand how to properly use these methods of contraception.

- Understanding of questionnaires: In the opinion of the investigator, subject possesses
a degree of understanding of the written questionnaires that enables the subject to
complete study participation.

- Informed consent: Capable of giving signed informed consent which includes compliance
with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria:

- Concurrent conditions / Medical History: Concomitant medical conditions defined as but
not limited to a historical or current evidence of clinically significant uncontrolled
disease of any body system (e.g., tuberculosis, psychological disorders, eczema,
uncontrolled diabetes, immunosuppression). Significant is defined as any disease that,
in the opinion of the investigator, would put the safety of the subject at risk
through study participation, or compromise the scientific validity of the study; A
respiratory infection at time of study participation; A condition associated with
anosmia (loss of smell) and ageusia (loss of taste) within 2 weeks of study - may be
self-reported condition experienced by the subject; Clinical evidence of a Candida
infection of the nose or oropharynx; Acute rhinosinusitis within 60 days of screening;
Current severe physical obstruction of the nose (e.g., deviated septum or nasal polyp)
or nasal septal perforation or nasal trauma or nasal ulcers; History of haemorrhagic
diathesis, atrophic rhinitis, or recurrent nasal bleeding which may, in the opinion of
the investigator, impact on the safety of the subject or the scientific validity of
the study; Nasal biopsy within 60 days of screening; Nasal jewellery or piercings
which could impact nasal safety or airway resistance; Rhinitis medicamentosa within 60
days of screening; History of glaucoma, cataracts or raised intraocular pressure.

- Concomitant medications: Use of intranasal corticosteroids (FF, MF or others) within 4
weeks of study participation; Recent or ongoing use of a corticosteroid by a non-nasal
route which, in the opinion of the investigator, could preclude subject participation
in the study; Use of intranasal medications (including intranasal antihistamines,
intranasal decongestants, intranasal saline) within 1 week of study participation; Use
of medications which, in the opinion of the investigator, could disturb the taste or
smell facultie


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rhinitis, Allergic, Perennial and Seasonal

Intervention(s)

Drug: FF nasal spray

Drug: MF nasal spray

Primary Outcome(s)

Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. [Time Frame: Approximately four minutes after the administration of the second treatment]

Secondary Outcome(s)

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire [Time Frame: Approximately four minutes after the administration of the second treatment]

Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Soothing [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat [Time Frame: Immediately following each treatment in Period 1 and 2]

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. [Time Frame: Approximatly two minutes after the dosing in Period 1 and 2]

Secondary ID(s)

201474

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/02/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02397915