Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomita… (NCT00070707) | Clinical Trial Compass
CompletedPhase 4
Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
188 participantsStarted 2003-04-03
Plain-language summary
This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.
Who can participate
Age range15 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have at least a two-year history of seasonal allergic rhinitis and an increase in asthma symptoms associated with the allergy season under study
* Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume increase of at least 200 ml, after reversibility testing within the past 12 months
* Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period.
* Female participants of childbearing potential use a medically accepted method of birth control and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of study agree and consent to use a medically acceptable method of birth control should they become sexually active while participating in the study.
Exclusion Criteria:
* Female participants who are pregnant, intend to become pregnant during the duration of the study, or are nursing.
* Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids.
* Have current or historical frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip.
* Have recent nasal se…
What they're measuring
1
Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)