A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Sleep-disordered Breathing Associated With Perennial Allergic Rhinitis (PAR) Using Home-Monitored Cardio-Respiratory Methodology.
Overview
- Phase
- Phase 4
- Intervention
- Mometasone furoate nasal spray
- Conditions
- Perennial Allergic Rhinitis
- Sponsor
- Organon and Co
- Enrollment
- 30
- Primary Endpoint
- Apnea-Hypopnea Index
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Demonstration of willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •Ages 18 to 60 years, of either sex, and of any race.
- •A 2-year or longer history of perennial allergic rhinitis (PAR) with or without SAR.
- •Skin test positive to a relevant prevalent perennial allergen or seasonal allergens if the subject also has SAR done either at the Screening Visit or within the previous 12 months.
- •At the Screening Visit (Visit 1) subject must have TNSS of \>=12 our of a possible 24, nasal congestion score of 4 out of a possible 6 on congestion, an Interference With Sleep average score of (2) moderate over 7 nights prior to the Screening Visit.
- •At the Baseline Visit (Visit 2) scores, reflective over the previous 12 hours, of 4 or more for nasal congestion using a categorical whole-number symptom severity scale encompassing 7 severity ratings on at least 6 of the 15 recordings of the Run-in period which may include the morning of the Baseline Visit (Visit 2).
- •At the Baseline Visit (Visit 2) subject must have a TNSS of more than \>=12 out of a possible 24 reflective over the past 12 hours on at least 6 or more of the 15 recordings of the Run-in period, which may include the morning of the Baseline Visit.
- •Current complaint of sleep disturbance while symptomatic with PAR and have a score of at least 2 with the Interference with Sleep scale on at least 4 out of the 8 AM diary recordings during the Run-in period and may include the morning of Visit 2 (Baseline).
- •The number of AH events per hour will be recorded but should not exceed 30 per hour.
- •Freedom from any clinically significant disease (other than PAR or SAR) that would interfere with the study evaluations.
Exclusion Criteria
- •Pregnant or intention to become pregnant during the study
- •Breast-feeding or intention to breast-feed during the study or within 30 days after study completion
- •Currently medication for PAR, or during the 10 days prior to the Screening Visit, treatment for SAR or PAR with an antihistamine or a nasal inhaled corticosteroid.
- •Current or a history of frequent (2 or more episodes per year for the past 2 years) clinically significant sinusitis or chronic purulent postnasal drip.
- •Recent nasal septum ulcers, nasal surgery, or nasal trauma; postpone inclusion until healing has occurred.
- •A diagnosis of rhinitis medicamentosa.
- •Upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to screening, or a viral upper or lower respiratory infection within 7 days prior to screening.
- •Nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfere with nasal airflow.
- •Bronchial asthma that cannot be controlled by short-acting beta 2-agonist adrenergic receptor agonists.
- •Current desensitization immunotherapy and expectation of receiving an increase in dose during the study. Subject may not receive desensitization treatment within 24 hours prior to a study visit.
Arms & Interventions
Mometasone furoate nasal spray
Intervention: Mometasone furoate nasal spray
Placebo nasal spray
Intervention: Placebo
Outcomes
Primary Outcomes
Apnea-Hypopnea Index
Time Frame: change from baseline (screening) at the end of 28 days of treatment
Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.