A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Per… (NCT00609674) | Clinical Trial Compass
CompletedPhase 4
A Clinical Study To Test A Nasal Spray (Fluticasone Furoate Nasal Spray) For The Treatment Of Perennial (Year-round) Allergic Rhinitis
United States315 participantsStarted 2008-01
Plain-language summary
The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
* Informed consent
* Subject has provided an appropriately signed and dated informed consent.
* An appropriately signed and dated assent must be obtained from the parents or guardian if the subject is a child under 18 years of age.
* Outpatient
* Subject is treatable on an outpatient basis.
* Age
* ≥ 12 years at Visit 2
* ≥ 18 years at Visit 1 for Russia and Germany
* Male or eligible female. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be performed for all females of childbearing potential at Visits 1, 2, 5, and Visit 6/Early Withdrawal to determine if the subject is pregnant.
To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
* Abstinence Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
* Oral contraceptive (either combined estrogen/progestin or progestin only),
* Injectable progestogen,
* Implants of levonorgestrel,
* Percutaneous contraceptive patches,
* Intrauterine device (IUD) or intrauterine s…
What they're measuring
1
Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Scores (rTNSS)
Timeframe: Daily; Baseline through End of Study (Week 4)