The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) A… (NCT00359216) | Clinical Trial Compass
CompletedPhase 4
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
30 participantsStarted 2006-05
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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…
What they're measuring
1
Apnea-Hypopnea Index
Timeframe: change from baseline (screening) at the end of 28 days of treatment