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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491504
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : April 5, 2010
Last Update Posted : March 13, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Mometasone Furoate Nasal Spray Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : February 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg total dose (2 sprays each nostril)
Drug: Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
Other Name: SCH 032088
Placebo Comparator: Placebo
Placebo (2 sprays each nostril)
Other: Placebo
Placebo: 2 sprays in each nostril

Primary Outcome Measures :
  1. Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 [ Time Frame: Baseline and 6 hours following initial dosing ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00491504     History of Changes
Other Study ID Numbers: P05073
First Posted: June 26, 2007    Key Record Dates
Results First Posted: April 5, 2010
Last Update Posted: March 13, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents