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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00730756
• Date of registration: 27/02/2008
• Primary sponsor: GlaxoSmithKline
• Public title: A Pilot Study In Adults And Adolescents With Irritant (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
• Date of first enrolment: March 2008
• Target sample size: 102
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00730756
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Thailand

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

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] assessments, 4 evening [PM] assessments) over the four 24-hour periods
prior to randomisation must be greater than/equal to 4.5.

- Average of the last 8 reflective nasal symptom assessments for congestion (4 AM
assessments, 4 PM assessments) over the four 24-hour periods prior to randomisation
must be greater than/equal to 2.

- A subject must have completed 80% of assessments on the screening symptom diary card.

Exclusion Criteria:

- 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 cont


Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Irritant (Non-Allergic) Rhinitis

Intervention(s)

Drug: Fluticasone Furoate Nasal Spray

Other: Placebo Nasal Spray

Primary Outcome(s)

Mean Change From Baseline in Daily rTNSS Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Secondary Outcome(s)

Mean Change From Baseline in AM and PM Reflective Individual Nasal Symptoms Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in AM and PM Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) [Time Frame: 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) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in AM Pre-dose Instantaneous Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in AM rTNSS, PM rTNSS, and AM Pre-dose iTNSS Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in Daily Reflective Individual Nasal Symptoms Score Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in Daily Reflective Individual Ocular Symptoms Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Mean Change From Baseline in Total Ocular Symptoms Over the Entire Treatment Period (28 Days) [Time Frame: Baseline through Week 4 (28 days)]

Secondary ID(s)

FFR111158

Source(s) of Monetary Support

Please refer to primary and secondary sponsors