Last updated: 11/04/2018 10:26:58
Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular symptoms associated with allergic rhinitis (AR).
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in Reflective Total Ocular Symptom Score (rTOSS)
Timeframe: Baseline to 14 days
Secondary outcomes:
Mean change from baseline in AM rTOSS
Timeframe: Baseline to 14 days
Mean change from baseline in PM rTOSS
Timeframe: Baseline to 14 days
Mean change from baseline in individual AM reflective ocular symptom scores for eye itching/burning
Timeframe: Baseline to 14 days
Mean change from baseline in individual PM reflective ocular symptom scores for eye itching/burning
Timeframe: Baseline to 14 days
Mean change from baseline in individual AM reflective ocular symptom scores for eye tearing/watering
Timeframe: Baseline to 14 days
Mean change from baseline in individual PM reflective ocular symptom scores for eye tearing/watering
Timeframe: Baseline to 14 days
Mean change from baseline in individual AM reflective ocular symptom scores for eye redness
Timeframe: Baseline to 14 days
Mean change from baseline in individual PM reflective ocular symptom scores for eye redness
Timeframe: Baseline to 14 days
Mean change from baseline in AM pre-dose instantaneous total ocular symptom scores (iTOSS)
Timeframe: Baseline to 14 days
Mean change from baseline in Reflective Nasal Congestion Symptom Score (rNCSS)
Timeframe: Baseline to 14 days
End-of-treatment assessment of response to therapy for ocular symptoms
Timeframe: Day 14
Mean change in objective assessment of conjunctival redness
Timeframe: Baseline to 14 days
Mean changes from baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) scores
Timeframe: Baseline to 14 days
Mean changes from baseline in individual MiniRQLQ scores: Domain - Activities
Timeframe: Baseline to 14 days
Mean changes from baseline in individual MiniRQLQ scores: Domain - Practical Problems
Timeframe: Baseline to 14 days
Mean changes from baseline in individual MiniRQLQ scores: Domain - Nose Symptoms
Timeframe: Baseline to 14 days
Mean changes from baseline in individual MiniRQLQ scores: Domain - Eye Symptoms
Timeframe: Baseline to 14 days
Mean changes from baseline in individual MiniRQLQ scores: Domain - Other Symptoms
Timeframe: Baseline to 14 days
Interventions:
Drug: Fluticasone propionate
Drug: Placebo
Enrollment:
626
Observational study model:
Not applicable
Primary completion date:
2013-28-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Allergic Rhinitis
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
December 2012 to February 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
Yes
- 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. 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:
Inclusion and exclusion 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 a) 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. b) 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: a) An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline). b) 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: a) injury or surgery to their nose that the investigator believes would interfere with participation in the study. b) 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. c) 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
Trial location(s)
Location
PPD Corporate Headquarters
Wilmington, NC, United States, 28401-3331
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-28-02
Actual study completion date
2013-28-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Related References DeWester 2003
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