An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma

NCT00599027 | Completed Phase 3 Results

• 1 other identifier: P05277
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Allergic Rhinitis; Asthma

Outcome Measures

Primary Outcomes (1)

• The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.

  To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.

  Baseline and 28 days of treatment

Study Arms (2)

Mometasone furoate nasal spray

EXPERIMENTAL

Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.

Drug: Mometasone furoate nasal spray (MFNS)

Placebo nasal spray

PLACEBO COMPARATOR

Placebo nasal spray once daily (two puffs per nostril) in the morning.

Drug: Placebo nasal spray

Interventions

Mometasone furoate nasal spray (MFNS) DRUG

Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.

Also known as: Nasonex Nasal Spray

Mometasone furoate nasal spray

Placebo nasal spray DRUG

Placebo nasal spray once daily (two puffs per nostril) in the morning.

Also known as: Placebo

Placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients (≥18 and ≤ 75 years of age) of either sex
• Willingness to participate and comply with procedures by signing a written informed consent
• Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks)
• To qualify at the randomization visit the daily average of the T5SS \[(Morning-time T5SS + Evening-time T5SS)/2\] had to be ≥ 6 in at least 4 days during the 1 week run-in period
• Positive (weal 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 were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level \>3.5 U/mL)
• All prior medication washout times had been observed
• Female volunteers of childbearing potential had to 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
• Negative urine pregnancy test
• Free of any clinically relevant disease that would have interfered with study evaluations
• Able to adhere to the dosing and visit schedules, and agree to record symptom severity scores and use of IMP and rescue medications in a daily diary

You may not qualify if:

• Female who was or intended to become pregnant during the study or within 12 weeks after study completion
• Nursing, or intended to be nursing during the study or within 12 months after study completion
• Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
• Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
• Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
• Rhinitis medicamentosa
• Evidence of persistent asthma, or asthma with daytime and nighttime symptoms not controlled by short-acting beta2-adrenoceptor agonists
• Asthma requiring chronic use of inhaled or systemic corticosteroids
• Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period, or had a viral upper respiratory infection within 7 days prior to screening
• Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
• Diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas)
• Concomitant medical problem
• Had 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
• Smoked or had smoked within the previous 6 months
• Member of the staff, affiliated with, or family member of the staff personnel directly involved with this study

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Baiardini I, Villa E, Rogkakou A, Pellegrini S, Bacic M, Compalati E, Braido F, Le Grazie C, Canonica GW, Passalacqua G. Effects of mometasone furoate on the quality of life: a randomized placebo-controlled trial in persistent allergic rhinitis and intermittent asthma using the Rhinasthma questionnaire. Clin Exp Allergy. 2011 Mar;41(3):417-23. doi: 10.1111/j.1365-2222.2010.03660.x. Epub 2010 Dec 1.

  PMID: 21121983 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 23, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 21, 2024
• Results First Posted: April 30, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share