A Pilot Study In Adults And Adolescents With Irritant (Non-Allergic) Rhinitis

NCT00730756 | Completed Phase 2 Results

• 1 other identifier: FFR111158
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this pilot study is to compare the effects (effectiveness and safety)of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]) with a placebo nasal spray for the treatment of irritant (non-allergic) rhinitis.

Conditions

Rhinitis, Allergic, Perennial

Keywords

Adolescents; Irritant(non-allergic)rhinitis; Adults; GW685698; Air Pollution

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days)

  The Total Nasal Symptom Score (TNSS) is the sum (scale 0-9) of the individual nasal scores for rhinorrhea, nasal congestion, and post-nasal drip. All symptoms were evaluated using a scale of 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe). Reflective (r) assessments were performed in the morning (AM) and evening (PM) and assessed the participant's symptoms over the preceding 12 hours. The daily reflective Total Nasal Symptoms Score (daily rTNSS) is the average of the AM and PM rTNSS. Mean change from baseline was calculated as the participant's treatment period mean minus the baseline mean.

  Baseline through Week 4 (28 days)

Secondary Outcomes (8)

• Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days)

  Baseline through Week 4 (28 days)

• Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days)

  Baseline through Week 4 (28 days)

• Mean Change From Baseline in AM Pre-dose Instantaneous Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)

  Baseline through Week 4 (28 days)

• Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days)

  Baseline through Week 4 (28 days)

• Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days)

  Baseline through Week 4 (28 days)

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Fluticasone Furoate Nasal Spray 110mcg intranasally once daily

Drug: Fluticasone Furoate Nasal Spray

Arm B

PLACEBO COMPARATOR

Matching placebo nasal spray intranasally once daily

Other: Placebo Nasal Spray

Interventions

Fluticasone Furoate Nasal Spray DRUG

Fluticasone furoate nasal spray 110mcg intranasally once daily for 4 weeks

Also known as: GW685698

Arm A

Placebo Nasal Spray OTHER

Matching placebo nasal spray intranasally once daily for 4 weeks

Arm B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Significant 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). 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 which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
• 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. A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Tantilipikorn P, Thanaviratananich S, Chusakul S, Benjaponpitak S, Fooanant S, Chintrakarn C, Jirapongsananuruk O, Visitsunthorn N, Toler T, Sutton L, Wu W, Lee L. Efficacy and Safety of Once Daily Fluticasone Furoate Nasal Spray for Treatment of Irritant (Non-allergic) Rhinitis. Open Respir Med J. 2010 Nov 3;4:92-9. doi: 10.2174/1874306401004010092.

  PMID: 21253453 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: August 8, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 6, 2017
• Results First Posted: November 25, 2009

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (5)