Acute Otitis Media
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTOP0201
OP0201 20mg per day in two divided doses for 10 days
COMBINATION_PRODUCTPlacebo
Placebo 0mg per day in two divided doses for 10 days
Oral Amoxicillin-clavulanate in two divided doses for 10 days
Sponsors
Novus Therapeutics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Days 1-28 | — |
| Evaluation of Efficacy (Otoscopy) | Day 4 | Percentage of study participants with no bulging tympanic membrane |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug: OP0201 + Antibiotics OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days | 56 |
| Placebo Comparator: Placebo + Antibiotics Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days | 47 |
| Total | 103 |
Baseline characteristics
| Characteristic | Placebo Comparator: Placebo + Antibiotics | Total | Drug: OP0201 + Antibiotics |
|---|---|---|---|
| Age, Continuous | 13.2 months STANDARD_DEVIATION 5.01 | 13.3 months STANDARD_DEVIATION 4.82 | 13.4 months STANDARD_DEVIATION 4.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 96 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 61 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 32 Participants | 16 Participants |
| Sex: Female, Male Female | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Male | 22 Participants | 55 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 48 |
| other Total, other adverse events | 48 / 55 | 36 / 48 |
| serious Total, serious adverse events | 0 / 55 | 1 / 48 |
Outcome results
Primary
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no middle ear effusion
Time frame: Day 12
Population: Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug: OP0201 + Antibiotics | Evaluation of Efficacy (Otoscopy) | 55.9 Percentage of participants |
| Placebo Comparator: Placebo + Antibiotics | Evaluation of Efficacy (Otoscopy) | 37.9 Percentage of participants |
Comparison: The summary statistics are based on subjects with non-missing data only.p-value: 0.07Regression, Logistic
Primary
Evaluation of Efficacy (Otoscopy)
Percentage of study participants with no bulging tympanic membrane
Time frame: Day 4
Population: Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug: OP0201 + Antibiotics | Evaluation of Efficacy (Otoscopy) | 51 Percentage of participants |
| Placebo Comparator: Placebo + Antibiotics | Evaluation of Efficacy (Otoscopy) | 47.3 Percentage of participants |
Comparison: The summary statistics are based on subjects with non-missing data only.p-value: 0.62Regression, Logistic
Primary
Number of Participants With Adverse Events
Time frame: Days 1-28
Population: Subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: OP0201 + Antibiotics | Number of Participants With Adverse Events | 48 Participants |
| Placebo Comparator: Placebo + Antibiotics | Number of Participants With Adverse Events | 36 Participants |