Assessment of Fluticasone Propionate on Ocular Allergy Symptoms

NCT01817790 | Completed Phase 3 Results

• 1 other identifier: RH01619
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis; Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)

  The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.

  Baseline to 14 days

Secondary Outcomes (18)

• Mean Change From Baseline in AM rTOSS

  Baseline to 14 days

• Mean Change From Baseline in PM rTOSS

  Baseline to 14 days

• Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning

  Baseline to 14 days

• Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning

  Baseline to 14 days

• Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering

  Baseline to 14 days

Study Arms (2)

Fluticasone propionate nasal spray

EXPERIMENTAL

Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.

Drug: Fluticasone propionate

Placebo nasal spray

PLACEBO COMPARATOR

Two sprays of placebo per nostril to be administered in morning.

Drug: Placebo

Interventions

Fluticasone propionate DRUG

Nasal spray formulation (200 mcg/day)

Also known as: Flonase

Fluticasone propionate nasal spray

Placebo DRUG

Vehicle for Fluticasone propionate aqueous nasal spray

Placebo nasal spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history
• Participants with diagnosis of seasonal allergic rhinitis
• 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.
• 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).
• Participants with allergic rhinitis symptom of at least moderate severity for randomization:
• An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline).
• An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in
• Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period.
• 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.

You may not qualify if:

• Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participants with nasal disorders like:
• injury or surgery to their nose that the investigator believes would interfere with participation in the study.
• 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.
• Rhinitis medicamentosa
• 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.
• Presence of or symptoms of an active bacterial or viral infection.
• Participants who have conjunctivitis caused by an infectious agent.
• Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

PPD Corporate Headquarters

Wilmington, North Carolina, 28401-3331, United States

Location

Related Publications (1)

• 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.

  PMID: 25624132 DERIVED

Related Links

• Related References DeWester 2003

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Seasonal

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2013-12

Locations

US (1)