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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02397915




Registration number
NCT02397915
Ethics application status
Date submitted
19/03/2015
Date registered
25/03/2015

Titles & IDs
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
Secondary ID [1] 0 0
201474
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhinitis, Allergic, Perennial and Seasonal 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF nasal spray
Treatment: Drugs - MF nasal spray

Experimental: Fluticasone Furoate - Subjects will receive a single dose of intranasal FF (total dose of 110 mcg) as 2 sprays per nostril / 4 sprays in total.

Experimental: Mometasone Furoate - Subjects will receive a single dose of intranasal MF (total dose of 200 mcg) nasal spray as 2 sprays per nostril / 4 sprays in total.


Treatment: Drugs: FF nasal spray
FF as a suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose x 4 doses (total dose 110 mcg) administered via a metered side-actuated nasal spray device.

Treatment: Drugs: MF nasal spray
MF as a suspension for intranasal inhalation with unit dose strength of 50 mcg per dose x 4 doses (total dose 200 mcg) administered via a metered top-actuated nasal spray device.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
Timepoint [1] 0 0
Approximately four minutes after the administration of the second treatment
Secondary outcome [1] 0 0
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Timepoint [1] 0 0
Approximately four minutes after the administration of the second treatment
Secondary outcome [2] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Timepoint [2] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [3] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Timepoint [3] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [4] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Timepoint [4] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [5] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Timepoint [5] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [6] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Timepoint [6] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [7] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Timepoint [7] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [8] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Timepoint [8] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [9] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Timepoint [9] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [10] 0 0
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Timepoint [10] 0 0
Immediately following each treatment in Period 1 and 2
Secondary outcome [11] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Timepoint [11] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [12] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Timepoint [12] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [13] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Timepoint [13] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [14] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Timepoint [14] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [15] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Timepoint [15] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [16] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Timepoint [16] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [17] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Timepoint [17] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [18] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Timepoint [18] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [19] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Timepoint [19] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [20] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Timepoint [20] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [21] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Timepoint [21] 0 0
Approximatly two minutes after the dosing in Period 1 and 2
Secondary outcome [22] 0 0
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Timepoint [22] 0 0
Approximatly two minutes after the dosing in Period 1 and 2

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 faculties of the subject; Use of any medications that significantly inhibit the cytochrome P450 (CYP) sub-family CYP3A4, including but not limited to ritonavir and ketoconazole, within 4 weeks of study participation.
* Relevant habits: Use of perfume or strong-smelling cosmetic products or oral rinse or similar products on the study day that could, in the opinion of the investigator, compromise participation in the study. Subjects should be notified of this criterion prior to study participation; Use of tobacco, or inhaled or oral nicotine-containing products, is not allowed for 12 hours prior to the start of dosing.
* Contraindications: History of sensitivity to any of the study procedures or medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* Diagnostic assessments and other criteria: Positive pregnancy test or female who is breastfeeding; The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer), unless more stringent local guidelines need to be followed.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2015
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [2] 0 0
GSK Investigational Site - Maroubra
Recruitment hospital [3] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2035 - Maroubra
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad Autónoma de Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Mendoza
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Incheon
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seongnam-si, Gyeonggi-do
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Moscow
Country [8] 0 0
Russian Federation
State/province [8] 0 0
Stavropol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02397915