The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)

Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis

The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography [CT] imaging of the sinuses).

Study Overview

• Status: Terminated
• Conditions: Sinusitis
• Intervention / Treatment: Drug: MFNS and antibiotic; Drug: Matching Placebo nasal spray plus antibiotic

• Study Type: Interventional
• Enrollment (Actual): 237
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be 12 years of age and older, of either sex, and of any race.
• Must weigh at least 40 kg (88 lb).
• Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Must have a clinical diagnosis of acute bacterial sinusitis.
• Must be symptomatic at the Screening and Baseline Visits on the basis of subject assessments of major symptoms score.
• Must have radiographic evidence of sinusitis on CT scans taken at Screening.
• Must be in general good health and free of any clinically significant disease (other than sinusitis) that would interfere with the study schedule or procedures, or compromise the subject's safety.
• A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis), vital signs, and electrocardiogram (ECG) recordings must be within normal limits or clinically acceptable to the investigator/qualified designee. Any test results that are questionable should be referred to the sponsor.
• A female subject of child-bearing potential must have a negative serum pregnancy (beta-hCG) test at Screening. She must agree to use a medically accepted method of contraception throughout the entire study period. Postmenopausal women will be exempted from the use of contraception during the study. Documented absence of menses for at least 1 year will indicate that a female is postmenopausal. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit. A female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.

Exclusion Criteria:

• A subject with moderate to severe persistent asthma that requires daily treatment with inhaled steroids, or an exacerbation of asthma within the past 30 days.
• A history of chronic sinusitis (symptoms lasting greater than 3 months) or having undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.
• A history of symptomatic seasonal allergic rhinitis and who, during the study period, is living in or traveling to locations where the allergen to which he/she is allergic is present.
• Subject with glaucoma or a history of posterior subcapsular cataracts.
• Subject with nasal polyps visible upon physical examination, immotile cilia syndrome, immunodeficiency disease, cystic fibrosis, clinically significant cardiovascular (including rheumatic heart disease), pulmonary, renal, hepatic, metabolic, hematological or neurologic disease that in the investigator's judgment might interfere with the evaluation of the therapy, or subjects who are immunocompromised, in renal failure, or on dialysis.
• Subject fails to observe the medication washout times outlined in the protocol prior to Screening.
• Subject has an allergy to corticosteroids or penicillins.
• Subject has used any investigational drug within 30 days of Screening.
• Subject has a concurrent need for antibiotic therapy other than study drug (amoxicillin/clavulanic acid).
• Subject is anticipating sinus or nasal surgery within the next month.
• Subject has been previously randomized into this study.
• Subject is part of the staff personnel directly involved with the study or is a family member of the investigational study staff involved in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MFNS + Antibiotic; Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID.	Drug: MFNS and antibiotic; MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days; Other Names: Group 1: MFNS + Antibiotic
Placebo Comparator: Placebo; Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID	Drug: Matching Placebo nasal spray plus antibiotic; Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days; Other Names: Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.	The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.	29-day Treatment Period and 2-week no-treatment Follow-up Period.
Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline	A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.	29-day Treatment Period and 2-week no-treatment Follow-up Period.

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 17, 2007
• First Submitted That Met QC Criteria: January 17, 2007
• First Posted (Estimate): January 18, 2007

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: P04824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php