A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Mometasone Furoate Nasal Spray in Subjects With Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
研究概览
简要总结
The purpose of this study is to provide information on whether subjects with allergic rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone furoate (MF) nasal spray based on how the products feel to the subjects when administered.
This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose, cross-over subject preference study to evaluate and compare patient preference for FF [(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate whether this difference is reflected in the patient-assessed attributes of the two nasal sprays. The attributes or properties which are being assessed by the subjects for these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to sneeze, and irritation.
The single-day study per subject comprises screening and all treatments and procedures. Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all subjects receive both products. One group of subjects will have two sprays of FF administered in each nostril whilst a second group will have two sprays of MF administered into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will switch. The first group will then have two sprays of MF administered into each nostril and the second group will then have two sprays of FF administered into each nostril. After each treatment the subject will complete two sets of attributes questionnaires ('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed immediately following each treatment and a subject-rated 'delayed' attributes questionnaire will be completed approximately 2 minutes after each treatment. Upon completion of the second set of these two attributes questionnaires (immediate and delayed), a preference questionnaire will be completed by the subject. In the preference questionnaire, the subject states their preferred treatment, if any, for each of the product attributes, and finally states their overall preferred treatment, if any.
There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after administration of the last treatment. The study is planned to enroll about 300 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: FF nasal spray (Drug)
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.
干预措施: MF nasal spray (Drug)
结局指标
主要结局
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
时间窗: Approximately four minutes after the administration of the second treatment
An overall preference questionnaire (OPQ) was used to evaluate participants' preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.
次要结局
- Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Soothing(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing(Immediately following each treatment in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.(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(Approximately four minutes after the administration of the second treatment)
- Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.(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.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed(Approximatly two minutes after the dosing in Period 1 and 2)
- Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.(Approximatly two minutes after the dosing in Period 1 and 2)