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

• Conditions: Acute Bacterial Sinusitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004925-42-Outside-EU/EEA
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-13
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. A subject must be 12 years of age and older, of either sex, and of any race.
2. A subject must weigh at least 40 kg (88 lb).
3. A subject (and/or parent/guardian) must be willing to give written informed consent and able to adhere to dose and visit schedules.
4. A subject must have a clinical diagnosis of acute bacterial sinusitis:
•The current acute episode must be of at least moderate severity, as assessed by the subject at the Screening Visit (overall condition scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe).
•There must have been a symptom-free period prior to this acute episode, as determined by subject history
5. A subject must be symptomatic at the Screening Visit, as follows:
Symptoms of sinusitis must be present for at least 5 but no more than 21 days as determined by subject history.
•A subject-evaluated PRIOR At least two symptoms of the MSS must be of moderate or greater severity (score =2).
•Purulent rhinorrhea and facial pain/pressure/tenderness must be present (score =1).
6. A subject must have radiographic evidence of sinusitis on CT scans taken at Screening, to include opacification of at least 10% in at least one of the maxillary sinuses.
7. A subject must be symptomatic at the Baseline Visit, as follows:
•The five twice-daily (AM and PM) run-in diary reflective (PRIOR) MSS, which consist of the 2 days prior to the Baseline Visit and the AM score at the Baseline Visit must total at least 30.
•Purulent rhinorrhea and facial pain/pressure/tenderness must be present (score =1), and at least two symptoms must be of moderate or greater severity (score =2), at the Baseline Day 1 AM evaluation.
8. A subject 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.
9. A subject’s clinical laboratory tests (hematology, blood chemistry, and urinalysis), vital signs, and 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.
10. 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. Postmenopausal women will be exempted from the use of contraception during the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 11
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 213
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

1. 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.
2. A subject with a history of chronic sinusitis (symptoms lasting greater than 3 months) or having undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.
3. A subject with a history of symptomatic seasonal allergic rhinitis (SAR) who, during the study period, are living in or traveling to locations where the allergen to which they are allergic is present.
4. A subject with glaucoma or a history of posterior subcapsular cataracts.
5. A 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.
6. A subject who fails to observe the medication washout times outlined in the protocol prior to Screening.
7. A subject with an allergy to corticosteroids or penicillins. A thorough history is to be taken and recorded on the source record.
8. A subject who has used any investigational drug within 30 days of Screening.
9. A subject with a concurrent need for antibiotic therapy other than study drug (amoxicillin/clavulanic acid).
10. A subject who is anticipating sinus or nasal surgery within the next month.
11. A subject who has been previously randomized into this study.
12. A subject who 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the efficacy of intranasal MFNS as an adjunctive treatment to antibiotic therapy in acute episodes of bacterial sinusitis. Efficacy is to be determined by the change from Baseline in AM/PM PRIOR major symptoms score (MSS) minus sinus headache averaged over Days 1 to 29 and the change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone.;Secondary Objective: To evaluate safety using vital signs, laboratory test results, and subject-reported adverse events.;Primary end point(s): •The change from Baseline in AM/PM PRIOR MSS minus sinus headache averaged over Days 1 to 29. <br>•The change in percent of opacification of the maxillary sinus.<br>;Timepoint(s) of evaluation of this end point: Subjects assessed and recorded the severity of their symptoms of sinusitis twice daily (in the morning [AM] and in the evening [PM]) during study.