Official Title: “An Exploratory Study of Mometasone Furoate Nasal Spray in Patients With Moderate-Severe Persistent Allergic Rhinitis and Intermittent Asthma: Effects on the Quality of Life Evaluated With the Rhinasthma Questionnaire”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

The primary objective is to explore the efficacy of mometasone furoate nasal spray (MFNS) in comparison with placebo in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score).

In addition, there are two secondary objectives. The first secondary objective is to evaluate the efficacy of MFNS in improving the quality of life of subjects with moderate to severe persistent allergic rhinitis and intermittent asthma as measured by the Rhinasthma Upper Airways Score, the Rhinasthma Lower Airways Score, and the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of MFNS in relieving the subject's symptoms of allergic rhinitis and asthma as measured by the Total 5 Symptoms Score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms) and by the use of rescue medication on demand.

Intervention(s) in this Clinical Trial

• Drug: Mometasone furoate nasal spray (MFNS)
  • MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD)
• Drug: Matching placebo nasal spray
  • Matching placebo nasal spray: 2 sprays in each nostril once daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Mometasone furoate nasal spray 200 mcg QD
• Placebo Comparator: Matching placebo nasal spray

Primary Measures

• The change in the Rhinasthma Global Summary Score from Baseline to the end of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No

Secondary Measures

• The change in the Rhinasthma Upper Airways Score from Baseline to the end of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No
• The change in the Rhinasthma Lower Airways Score from Baseline to the end of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No
• The change in the Rhinasthma Respiratory Allergy Impact Score from Baseline to the end of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No
• The change in the T5SS from Baseline to the weekly-score averaged over the last week (Days 21 to 28) of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No
• The change in the Global Symptom Score from Baseline to the weekly-score averaged over the last week (Days 21 to 28) of the treatment period.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No
• The number of subjects using rescue medication at least once during the entire study.
  • Time Frame: After 28 days of treatment.
    Safety Issue?: No

Inclusion Criteria:

• Subjects must be outpatients between the ages of 18 and 75 years, inclusive, and of either sex.
• Subjects must have moderate to severe persistent allergic rhinitis with a history of intermittent asthma of at least 2 years and actual asthma (symptoms in the last 4 weeks).
• Subjects must be clinically symptomatic at the randomization visit.
• A positive (wheal 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 are required for at least house dust mite and one pollen allergen (grass or Parietaria, IgE level >3.5
• U/mL). The SPTs should have been performed with a standard panel of allergens common in the region, including the following: dust mites, grasses, parietaria, birch, alder, olive, cypress, cat, dog, Alternaria, and Aspergillus.
• Female subjects 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 (i.e., women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study.
• Female subjects of childbearing potential must have a negative urine pregnancy test at screening.

Exclusion Criteria:

• Subject is a female who is pregnant or nursing, or who intends to become pregnant or nursing during the study or within 12 months after study completion.
• Subject has anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps) that would interfere with nasal airflow.
• Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants.
• Subject has rhinitis medicamentosa.
• Subject has evidence of persistent asthma, or asthma with daytime and night-time symptoms not controlled by short-acting beta2-adrenoceptor agonists.
• Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
• Subjects who have had an upper respiratory tract or sinus infection that requires antibiotic therapy and have not had at least a 14 day wash-out period prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening.
• Subject has a dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
• Subject is currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit and wish to remain on this schedule during the study are eligible for study inclusion; however, subject may not receive hyposensitization treatment within 24 hours prior to any study visit.
• Subject has been diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas).
• Subject has a concomitant medical problem that may interfere with participation in the study; e.g., repeated migraine episodes, uncontrolled convulsive disorders.
• Subject has any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
• Subject smokes, or is an ex-smoker who has smoked within the previous 6 months.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00599027

Study ID Number: P05277

ClinicalTrials.gov Identifier: NCT00599027

Health Authority: Italy: Ethics Committee