Clinical trial NCT01817790: Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy of Once-Daily Fluticasone Propionate Aqueous Nasal Spray 200mcg for 14 Days on Ocular Symptoms Associated With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Seasonal Allergic Rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-03-25
Enrollment: 626
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).

Detailed description: While the current FP approved indication for GSK marketed formulation is limited to the treatment of nasal symptoms, several large well-controlled studies in which FP maintained adequate control of nasal symptoms when administered in a dose of 200 micrograms (mcg) once-daily (QD) also suggested improvement in ocular symptoms. This study will employ a randomized, double-blind, parallel group, multi-center design that compares FP and placebo nasal sprays in subjects with seasonal allergic rhinitis (SAR) to assess the effectiveness on ocular symptoms associated with AR.

Eligibility criteria: Inclusion Criteria:

1. Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history
2. Participants with diagnosis of seasonal allergic rhinitis

   1. A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal and ocular allergy symptoms during each of the last 2 mountain cedar pollen allergy seasons.
   2. A positive skin test reaction to (at least) the relevant allergen, mountain cedar pollen, as determined by the skin pricks method performed within 12 months of Visit 1).
3. Participants with allergic rhinitis symptom of at least moderate severity for randomization:

   1. An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline).
   2. An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in
4. Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period.
5. Participant demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent/assent and has received a signed and dated copy of the informed consent/assent form. Children, ages 12 to 17 will be required to sign an assent form as part of the informed consent process.

Exclusion Criteria:

1. Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
2. Participants with nasal disorders like:

   1. injury or surgery to their nose that the investigator believes would interfere with participation in the study.
   2. previously diagnosed with a severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug.
   3. Rhinitis medicamentosa
3. Participants who have historical or current evidence of clinically significant uncontrolled disease like asthma, cardiac arrhythmias, hypertension, diabetes mellitus, ocular herpes, glaucoma, hepatic or renal disease, malignancy etc.
4. Presence of or symptoms of an active bacterial or viral infection.
5. Participants who have conjunctivitis caused by an infectious agent.
6. Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months

Primary outcomes:
measure: Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: Mean Change From Baseline in AM rTOSS
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in PM rTOSS
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)
timeFrame: Baseline to 14 days
measure: Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)
timeFrame: Baseline to 14 days
measure: End-of-treatment Assessment of Response to Therapy for Ocular Symptoms
timeFrame: Day 14
measure: Mean Change in Objective Assessment of Conjunctival Redness
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms
timeFrame: Baseline to 14 days
measure: Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: PPD Corporate Headquarters
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ratner P, Van Bavel J, Mohar D, Jacobs RL, Hampel F, Howland W, Karwal R. Efficacy of daily intranasal fluticasone propionate on ocular symptoms associated with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2015 Feb;114(2):141-7. doi: 10.1016/j.anai.2014.11.012.