An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis … (NCT00599027) | Clinical Trial Compass
CompletedPhase 3
An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
51 participantsStarted 2008-05
Plain-language summary
The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate nasal spray) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of allergic rhinitis and asthma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Outpatients (≥18 and ≤ 75 years of age) of either sex
* Willingness to participate and comply with procedures by signing a written informed consent
* Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
* To qualify at the randomization visit the daily average of the T5SS \[(Morning-time T5SS + Evening-time T5SS)/2\] had to be ≥ 6 in at least 4 days during the 1 week run-in period
* Positive (weal diameter \>3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level \>3.5 U/mL)
* All prior medication washout times had been observed
* Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication
* Negative urine pregnancy test
* Free of any clinically relevant disease that would have interfered with study evaluations
* Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary
Exclusion Criteria:
* Female who was or intended to become pregnant during the study or within 12 weeks after study completion
* Nursing, or intende…
What they're measuring
1
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.