This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)

Seasonal Allergic Rhinitis Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Induced Seasonal Allergic Rhinitis (SAR) in an Environmental Exposure Chamber (EEC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491504
• Other study ID #: P05073
• Status: Completed
• Phase: Phase 4
• Start date: February 2007
• Est. completion date: July 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Willing to participate and to adhere to dose and visit schedules
• 18 to 65 years, either sex, any race
• 2-year history of SAR, being symptomatic during the last 2 ragweed seasons
• Skin test positive to short ragweed allergen at screening, or positive within 12 months
• Women must practice adequate contraception: Females of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must 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. Women who are postmenopausal for >1 year (ie, women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.; Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation)
• Negative pregnancy tests during study

Exclusion Criteria:

• Compromised ability to provide informed consent
• Nasal abnormalities, including large nasal polyps, and marked septum deviation that interferes with nasal airflow at screening
• Recent (within the last 2 weeks) or unhealed nasal septum ulcers, nasal surgery, or nasal trauma
• Unstable asthma which cannot be controlled with inhaled short-acting beta-2 agonists
• Diagnosed with sinusitis within the previous 2 weeks
• Is initiating or is currently on advanced immunotherapy
• If on immunotherapy (desensitization therapy), the subject must be stable and should not receive an increase in dose during the study. Subjects may not receive desensitization treatment within 24 hours prior to a study visit
• Is currently on or has been on an antihistamine, decongestant (topical or systemic) or a nasal inhaled corticosteroid during the 14 days prior to the first priming visit
• Unable to refrain from regular use of nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
• Failed the designated washout periods for any of the prohibited medications
• Upper or lower respiratory tract or sinus infection that required antibiotic therapy or a viral upper or lower respiratory infection within 14 days prior to screening
• Is allergic to or has sensitivity to the study drug or its excipients
• Used any investigational product within 30 days before enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days
• Subject has Chronic obstructive pulmonary disease, Alcohol abuse, Rhinitis medicamentosa

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)

Other:
• Placebo
Placebo: 2 sprays in each nostril

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Salapatek AM, Patel P, Gopalan G, Varghese ST. Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):433-8. doi: 10.2500/ajra.2010.24.3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1	Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score =6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score =2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.	Baseline and 6 hours following initial dosing