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A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

Primary Purpose

Recurrent Wheezing, Wheezing Lower Respiratory Illness

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OM-85
Placebo
Sponsored by
OM Pharma SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Wheezing focused on measuring Innate immune response, Type 1 immune response, Type 2 immune response, Bacterial lysate, Immunomodulation, EAGLE

Eligibility Criteria

6 Months - 72 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who meet all the following criteria will be included in the study: Children of either gender, aged between 6 and 72 months (5 years inclusive). Children with recurrent wheezing: For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy. Up-to-date vaccination status as per applicable State Vaccination Requirements for school/day-care entry. Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures. Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week. Exclusion Criteria: Known anatomic alterations of the respiratory tract. Wheezing documented to be caused by gastroesophageal reflux. Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis). Any known autoimmune disease. Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency). Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities. Children born prematurely i.e., before 34 weeks of gestational age. Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator. Any known neoplasia or malignancy. Treatment with the following medications: Systemic (intravenous or intramuscular) or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment. Any major surgery within the last 3 months prior to study enrollment. Known allergy or previous intolerance to investigational drug. Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study. Other household members have previously been randomized in this clinical study. Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study). Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s). Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.

Sites / Locations

  • Arizona Medical ClinicRecruiting
  • Phoenix Children's HospitalRecruiting
  • The University of Arizona Medical Center - University Campus
  • Arkansas Children's Hospital Research InstituteRecruiting
  • Kern Research Inc.Recruiting
  • Hoag Health Center Foothill RanchRecruiting
  • UCSF Benioff Children's Hospital Oakland Primary Care Clinic
  • Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and ImmunologyRecruiting
  • Rady Children's HospitalRecruiting
  • Children's Hospital Colorado - Pediatric Heart Lung Center - PediatricsRecruiting
  • BioMD Clinical ResearchRecruiting
  • C & R Research Services USA. IncRecruiting
  • Rush University Medical CenterRecruiting
  • Riley Children's Health - Pediatrics
  • Allergy & Asthma Specialists PSCRecruiting
  • Boston Children's Hospital
  • Northwell Health/Division of Allergy & ImmunologyRecruiting
  • UNC Hospitals, The Univ of NC at Chapel Hill
  • Cincinnati Children'S Hospital Medical CenterRecruiting
  • Allergy, Asthma and Clinical Research CenterRecruiting
  • Vital Prospects Clinical Research Institute, PCRecruiting
  • Monroe Carell Jr. Children's Hospital
  • La Providence Pediatrics ClinicRecruiting
  • Prime Clinical Research IncRecruiting
  • ARC Clinical Research at Kelly Lane
  • STAAMP ResearchRecruiting
  • The University of Texas Health Science Center at Tyler - PulmonologyRecruiting
  • University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OM-85

Placebo

Arm Description

Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.

Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.

Outcomes

Primary Outcome Measures

Rate of Wheezing/Asthma like episodes (WEs)
To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.

Secondary Outcome Measures

Rate of severe WEs
To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.
Number of oral corticosteroid (OCS) treatments during 6-month treatment period
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month Treatment period.
Number of days with WEs
To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs compared to placebo during the 6-month Treatment period.
Rate of WEs and severe WEs
To assess the efficacy of OM-85 compared to placebo in reducing the rate of WEs and severe WEs during the 6-month Observational period.
Number of OCS treatments during 6-month observational period
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.
Duration in days of WEs and severe WEs
To assess the efficacy of OM-85 compared to placebo in reducing the duration of WEs and of severe WEs during the 6-month Treatment period and the 6-month Observational period.
Time to treatment failure
To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.
Time to first, second and third WE
To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.
Number of routine asthma treatment
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The number of routine asthma treatment will be assessed.
Duration of routine asthma treatment
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The duration of routine asthma treatment will be assessed.
Percentage of patients with recurrent wheezing
To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with ≥1 WEs during the 6-month treatment period and the 6-month observational period.
Number of days with respiratory tract infection (RTIs) symptoms
To assess the efficacy of OM-85 compared to placebo in reducing the number of days with RTI symptoms during the 6-month treatment period and the 6-month observational period.
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)
To assess the efficacy of OM-85 compared to placebo in reducing the severity of RTI symptoms during the 6-month treatment period and the 6-month observational period. RTI symptoms severity will be assessed based on the symptom evaluation in the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), other relevant symptoms indicative of an RTI (e.g., headache, body aches), and tympanic temperature as recorded by patient's parents or legally authorized representative (LAR). Severity of symptoms will be determined by using the following definitions: child does not have this = absent (no sign/symptom evident); a little bad = mild (sign/symptom clearly present but easily tolerated); bad = moderate (definite awareness of sign/symptom that is bothersome but tolerable); and very bad = severe (sign/symptom that is hard to tolerate and causes interference with activities of daily life and/or sleeping).
Number of antibiotic cycles
To assess the efficacy of OM-85 compared to placebo in reducing the antibiotics treatment for an RTI during the 6-month treatment period and the 6-month observational period.
Number of medical visits
To assess the efficacy of OM-85 compared to placebo in reducing the number of medical visits (hospitalizations, visits to emergency rooms, or to a physician/health care provider) due to respiratory events during the 6-month treatment period and the 6-month observational period.
Number of days absent from daycare/school
To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Number of patients with adverse events (AEs)
To assess the safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month treatment period and the 6-month observational period.

Full Information

First Posted
May 4, 2023
Last Updated
September 29, 2023
Sponsor
OM Pharma SA
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1. Study Identification

Unique Protocol Identification Number
NCT05857930
Brief Title
A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
August 28, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OM Pharma SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing
Detailed Description
This study is a 12-months phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of daily treatment with OM-85 compared to placebo, when given on top of standard of care treatment, in reducing wheezing/asthma like episodes (WEs) during the 6-month treatment period in children aged 6 months to 5 years with previous recurrent WEs. Patients will be randomized in a 1:1 ratio to OM-85 or placebo. The study consists of screening period (Day -20 to Day -1), a treatment period of 6 months, and an observational period of 6 months without treatment. Thus, the total duration of the study for each patient will be 12 months (±10 days) + up to 20 days for screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Wheezing, Wheezing Lower Respiratory Illness
Keywords
Innate immune response, Type 1 immune response, Type 2 immune response, Bacterial lysate, Immunomodulation, EAGLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OM-85
Arm Type
Experimental
Arm Description
Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
Intervention Type
Drug
Intervention Name(s)
OM-85
Intervention Description
OM-85 capsule (3.5mg) contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule contents will be mixed with adequate quantity of water, fruit juice or milk/formula and orally administered once a day for 6 consecutive months.
Primary Outcome Measure Information:
Title
Rate of Wheezing/Asthma like episodes (WEs)
Description
To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Rate of severe WEs
Description
To assess the efficacy of OM-85 in reducing the rate of severe WEs compared to placebo during the 6-month Treatment period.
Time Frame
6 Months
Title
Number of oral corticosteroid (OCS) treatments during 6-month treatment period
Description
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs compared to placebo during the 6-month Treatment period.
Time Frame
6 Months
Title
Number of days with WEs
Description
To assess the efficacy of OM-85 to decrease the cumulative number of days with WEs compared to placebo during the 6-month Treatment period.
Time Frame
6 Months
Title
Rate of WEs and severe WEs
Description
To assess the efficacy of OM-85 compared to placebo in reducing the rate of WEs and severe WEs during the 6-month Observational period.
Time Frame
From Month 6 up to Month 12
Title
Number of OCS treatments during 6-month observational period
Description
To assess the efficacy of OM-85 in reducing the use of oral corticosteroids for WEs vs. placebo during the 6-month observational period.
Time Frame
From Month 6 up to Month 12
Title
Duration in days of WEs and severe WEs
Description
To assess the efficacy of OM-85 compared to placebo in reducing the duration of WEs and of severe WEs during the 6-month Treatment period and the 6-month Observational period.
Time Frame
12 Months
Title
Time to treatment failure
Description
To assess the efficacy of OM-85 compared to placebo to prolong time to treatment failure, during the whole study period.
Time Frame
12 Months
Title
Time to first, second and third WE
Description
To assess the efficacy of OM-85 compared to placebo to prolong the time to first, second, and third WE.
Time Frame
12 Months
Title
Number of routine asthma treatment
Description
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The number of routine asthma treatment will be assessed.
Time Frame
12 Months
Title
Duration of routine asthma treatment
Description
To assess the efficacy of OM-85 compared to placebo to reduce the amount of routine asthma treatment required to control acute WEs during the 6-month treatment period and the 6-month observational period. The duration of routine asthma treatment will be assessed.
Time Frame
12 Months
Title
Percentage of patients with recurrent wheezing
Description
To assess the efficacy of OM-85 compared to placebo in reducing the percentage of patients with ≥1 WEs during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months
Title
Number of days with respiratory tract infection (RTIs) symptoms
Description
To assess the efficacy of OM-85 compared to placebo in reducing the number of days with RTI symptoms during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months
Title
Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)
Description
To assess the efficacy of OM-85 compared to placebo in reducing the severity of RTI symptoms during the 6-month treatment period and the 6-month observational period. RTI symptoms severity will be assessed based on the symptom evaluation in the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K), other relevant symptoms indicative of an RTI (e.g., headache, body aches), and tympanic temperature as recorded by patient's parents or legally authorized representative (LAR). Severity of symptoms will be determined by using the following definitions: child does not have this = absent (no sign/symptom evident); a little bad = mild (sign/symptom clearly present but easily tolerated); bad = moderate (definite awareness of sign/symptom that is bothersome but tolerable); and very bad = severe (sign/symptom that is hard to tolerate and causes interference with activities of daily life and/or sleeping).
Time Frame
12 Months
Title
Number of antibiotic cycles
Description
To assess the efficacy of OM-85 compared to placebo in reducing the antibiotics treatment for an RTI during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months
Title
Number of medical visits
Description
To assess the efficacy of OM-85 compared to placebo in reducing the number of medical visits (hospitalizations, visits to emergency rooms, or to a physician/health care provider) due to respiratory events during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months
Title
Number of days absent from daycare/school
Description
To assess the efficacy of OM-85 compared to placebo in reducing the number of days of absence from daycare/school due to respiratory events during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months
Title
Number of patients with adverse events (AEs)
Description
To assess the safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent WEs during the 6-month treatment period and the 6-month observational period.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who meet all the following criteria will be included in the study: Children of either gender, aged between 6 and 72 months (5 years inclusive). Children with recurrent wheezing: For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including at least one that triggered an unscheduled physician visit, in the 12 months prior to enrollment. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy. Up-to-date vaccination status as per applicable State Vaccination Requirements for school/day-care entry. Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures. Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week. Exclusion Criteria: Known anatomic alterations of the respiratory tract. Wheezing documented to be caused by gastroesophageal reflux. Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis). Any known autoimmune disease. Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency). Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities. Children born prematurely i.e., before 34 weeks of gestational age. Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator. Any known neoplasia or malignancy. Treatment with the following medications: Systemic (intravenous or intramuscular) or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment. Any major surgery within the last 3 months prior to study enrollment. Known allergy or previous intolerance to investigational drug. Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study. Other household members have previously been randomized in this clinical study. Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study). Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s). Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenz Lehr
Phone
+41 22 7831459
Email
lorenz.lehr@ompharma.com
Facility Information:
Facility Name
Arizona Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Arizona Medical Center - University Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Name
Kern Research Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Individual Site Status
Recruiting
Facility Name
Hoag Health Center Foothill Ranch
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Benioff Children's Hospital Oakland Primary Care Clinic
City
Oakland
State/Province
California
ZIP/Postal Code
94618
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-7106
Country
United States
Individual Site Status
Recruiting
Facility Name
BioMD Clinical Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
C & R Research Services USA. Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Riley Children's Health - Pediatrics
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Allergy & Asthma Specialists PSC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwell Health/Division of Allergy & Immunology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Individual Site Status
Recruiting
Facility Name
UNC Hospitals, The Univ of NC at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cincinnati Children'S Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Monroe Carell Jr. Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37821
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
La Providence Pediatrics Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77071
Country
United States
Individual Site Status
Recruiting
Facility Name
Prime Clinical Research Inc
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States
Individual Site Status
Recruiting
Facility Name
ARC Clinical Research at Kelly Lane
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Terminated
Facility Name
STAAMP Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Tyler - Pulmonology
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708-3154
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-9988
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

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