Efficacy and safety study for Fluticasone Furoate Nasal Spray in adults and adolescents with non-allergic rhinitis.

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2015-004888-37-Outside-EU/EEA
• Date of registration: 03/08/2016
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Research and Development Ltd
• Public title: Efficacy and safety study for Fluticasone Furoate Nasal Spray in adults and adolescents with non-allergic rhinitis.
• Scientific title: A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents with Irritant (Non-Allergic) Rhinitis
• Target sample size: 102
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004888-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Thailand

Contacts

• Name: GSK Clinical Support Help Desk
• Affiliation: GlaxoSmithKline Research & Development Ltd

• Name: GSK Clinical Support Help Desk
• Affiliation: GlaxoSmithKline Research & Development Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Informed consent: Subject is willing and able to provide consent to participate in the study. For subjects who are under 18 years of age, an appropriately signed and dated assent must be obtained from the parents or guardian.
- Outpatient: Subject is treatable on an outpatient basis.
- Age: 12 years of age or older at Visit 2.
- Gender: Male or eligible female
To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Implants of levonorgestrel
• Injectable progestogen
• Oral contraceptive (either combined estrogen/progestin or progestin only)
• Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or
• Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
• Double barrier method - spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed at the screening visit (Visit 1), the randomisation visit (Visit 2) and at the final visit (Visit 6 or Early Withdrawal).
- Clinical history: Diagnosis or evidence of air pollution triggers as the predominant irritant trigger for their rhinitis symptoms to include ALL of the following:
• A two year clinical history of irritant (non-allergic) rhinitis triggered predominantly by air pollution exposure (written or verbal confirmation) in the opinion of the investigator and evidence of symptoms such as rhinorrhea, nasal congestion and postnasal drip relating to concentration of air particulates, air quality and levels of exposure.
• Based on the trigger questionnaire, subjects must indicate that air pollution is the predominant trigger that makes their rhinitis symptoms worse completed at Visit 1.
• Negative skin test (by prick method) response to seasonal allergens (including tree, grass and weed pollens) and perennial allergens (including animal dander, house dust mites, cockroach and mould) relevant to the geographical area completed at Visit 1.
A negative response for allergen skin prick testing is defined as a wheal <3 mm than the diluent control.
• Positive response to a histamine skin test (prick method) completed at Visit 1.
A positive response for histamine skin prick testing is defined as a wheal =3 mm larger than the diluent control.
• Normal sinus radiograph (Waters view) to rule out sinusitis (presence of mucosal thickening of =6 mm at the point of maximal thickening or an air fluid level or opacification). The sinus radiograph will be scheduled at Visit 1.

- Ability to comply with study procedures: Subject understands and is willing, able and likely to comply with study procedures and restrictions.
- Literate: Subject must be able to read, comprehend, and record information in English or native language.

Randomization Criteria
- Average of the last 8, reflective, total nasal symptom score (rTNSS) assessments (4 morning [AM] asse
Exclusion criteria:
• historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). • a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of double blind intranasal study drug
• nasal (e.g., nasal septum) or ocular injury/surgery in the last 3 months
• asthma, with the exception of mild intermittent asthma [Global Initiative for Asthma (GINA), 2006]. NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
• rhinitis medicamentosa
• bacterial or viral infection (e.g., common cold) of the upper respiratory tract within two weeks of Visit 1 or during the screening period
• documented evidence of acute or significant chronic sinusitis, as determined by a sinus radiograph (Waters view) done at Visit 1
• current or history of glaucoma and/or current cataract or ocular herpes simplex
• physical impairment that would affect the subject's ability to participate in the study
• clinical evidence of a Candida infection of the nose or oropharynx
• history of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
• history of or current use of cocaine
• history of adrenal insufficiency
• Chickenpox or measles within 3 weeks of Visit 1.- Use of corticosteroids, defined as:
• Intranasal corticosteroid within 4 weeks prior to Visit 1.
• Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less, or equivalent) within 8 weeks prior to Visit 1.
- Use of other allergy medications within the timeframe indicated relative to Visit 1
• Intranasal or ocular cromolyn within 14 days prior to Visit 1
• Short-acting prescription and over the counter (OTC) antihistamines, including ocular preparations and antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 7 days prior to Visit 1
• Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine
• Long-acting antihistamine, astemizole, within 12 weeks prior to Visit 1
• Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1
• Oral or intranasal decongestants within 3 days prior to Visit 1
• Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1
• Oral antileukotrienes within 3 days prior to Visit 1
• Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
• Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
• Ocular antihistamines, artificial tears, eyewashes/nasal irrigation solutions, homeopathic preparations, lubricants, sympathomimetic or vasoconstrictor preparations during the screening or treatment periods. No exclusion period prior to screening (Visit 1) is required for these treatments.
• Throat treatments (e.g., cough lozenges, throat sprays) during the screening and treatment periods.
- Use of other medications that may affect irritant rhinitis or its symptoms
• Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Irritant (non-allergic) rhinitis

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Trade Name: Veramyst,Avamys,Allermist
Pharmaceutical Form:
INN or Proposed INN: FLUTICASONE FUROATE
CAS Number: 397864-44-7
Current Sponsor code: FLUTICASONE FUROATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.05-

Primary Outcome(s)

Main Objective: To compare the efficacy and safety of fluticasone furoate nasal spray 110 mcg (FFNS) once daily with placebo nasal spray in subjects with irritant (non-allergic) rhinitis triggered predominantly by air pollution

Secondary Objective: Not applicable

Primary end point(s): Mean change from baseline over the entire treatment period in daily reflective total nasal symptom scores (daily rTNSS)

Timepoint(s) of evaluation of this end point: Week 1-4 (on-going)

Secondary Outcome(s)

Secondary end point(s): Nasal Symptoms
Mean change from baseline over the entire treatment period in morning (AM) pre-dose instantaneous total nasal
symptom scores (AM predose iTNSS)
Mean change from baseline over the entire treatment period in AM rTNSS
Mean change from baseline over the entire treatment period in evening (PM) rTNSS
Mean change from baseline over the entire treatment period in individual (1) daily reflective, (2) AM pre-dose
instantaneous, (3) AM reflective, and (4) PM reflective nasal symptom scores for rhinorrhea, nasal congestion, and
postnasal drip.
Ocular Symptoms
Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score
(rTOSS).
Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total ocular symptoms
scores (iTOSS)
Mean change from baseline over the entire treatment period in AM rTOSS
Mean change from baseline over the entire treatment period in PM rTOSS
Mean change from baseline over the entire treatment period in individual (1) daily reflective, (2) AM pre-dose
instantaneous, (3) AM reflective, and (4) PM reflective nasal symptom scores for eyes itching/ burning, eye
tearing/watering, eye redness

Timepoint(s) of evaluation of this end point: Week 1-4 (on-going)

Secondary ID(s)

FFR111158

Source(s) of Monetary Support

GlaxoSmithKline