A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months

The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and children.

Study Overview

• Status: Completed
• Conditions: Acute Otitis Media
• Intervention / Treatment: Combination product: OP0201; Drug: Amoxicillin-clavulanate; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics Oakland Medical Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria includes but is not limited to:

1. Male and female infants and children aged ≥6 months to ≤24 months
2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent [less than 48 hours] onset of ear pain or intense erythema of the TM
3. Score of 5 or more on the 5 question version of AOM-SOS scale1
4. Written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and Parent/Caregiver assessments are recorded according to the study protocol.
5. Intact tympanic membrane (TM) in both ears (e.g., no perforation)

Exclusion Criteria includes but is not limited to:

1. Allergy to penicillin or cephalosporin
2. History or presence of immunodeficiency disorders
3. Antimicrobial therapy within the 3 days (i.e., 72 hours) prior to Day 1
4. Craniofacial abnormalities (e.g., cleft palate or Down's Syndrome) that may interfere with Eustachian tube function
5. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
6. Clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Drug: OP0201 + Antibiotics; OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days	Combination product: OP0201; OP0201 20mg per day in two divided doses for 10 days; Drug: Amoxicillin-clavulanate; Oral Amoxicillin-clavulanate in two divided doses for 10 days
PLACEBO_COMPARATOR: Placebo Comparator: Placebo +Antibiotics; Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days	Drug: Amoxicillin-clavulanate; Oral Amoxicillin-clavulanate in two divided doses for 10 days; Combination product: Placebo; Placebo 0mg per day in two divided doses for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events		Days 1-28
Evaluation of Efficacy (Otoscopy)	Percentage of study participants with no bulging tympanic membrane	Day 4
Evaluation of Efficacy (Otoscopy)	Percentage of study participants with no middle ear effusion	Day 12

Collaborators and Investigators

• Sponsor: Novus Therapeutics, Inc

Publications and helpful links

General Publications

• Muniz GB, Shope TR, Bhatnagar S, Shaikh N, Haralam MA, Liu H, Martin JM, Pogoda JM, Hoberman A. Intranasal Surfactant for Acute Otitis Media: A Randomized Trial. Pediatrics. 2021 Dec 1;148(6):e2021051703. doi: 10.1542/peds.2021-051703.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2019
• Primary Completion (ACTUAL): March 9, 2020
• Study Completion (ACTUAL): March 26, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (ACTUAL): January 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: OP0201-C-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No