Lyophilized bacterial lysates of: Haemophilus influenzae, Streptococcus (diplococcus) pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Moraxella (Branhamella / Neisseria) catarrhalis (Standardised OM-85 lyophilisate) for Recurrent wheezing | Chronic wheezing

Inclusion criteria

• {"criterion_text":"- Children of either gender, aged between 6 and 72 months (5 years inclusive)."}
• {"criterion_text":"- Children with recurrent wheezing: a. For ICS/LTRA naïve patients or intermittent users: ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, as reported by parents or LAR of subject, in the 12 months prior to enrollment. b. For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS or having triggered an ED visit/hospitalization) OR ≥2 WEs including 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. Note: While WE counted for enrollment are based on parent reporting, the PI must ensure that they fulfill the WE definition of the protocol."}
• {"criterion_text":"- Up-to-date vaccination status as per applicable State Or Country Vaccination Requirements for school/daycare entry."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Known anatomic alterations of the respiratory tract."}
• {"criterion_text":"- Treatment with the following medications: a. Systemic (intravenous or intramuscular) or oral corticosteroids or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment."}
• {"criterion_text":"- Any major surgery within the last 3 months prior to study enrollment or planned during the study duration."}
• {"criterion_text":"- Known allergy or previous intolerance to investigational drug."}
• {"criterion_text":"- Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study."}
• {"criterion_text":"- Other household members have previously been randomized in this clinical study."}
• {"criterion_text":"- Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study)."}
• {"criterion_text":"- Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s)."}
• {"criterion_text":"- Wheezing documented to be caused by gastroesophageal reflux."}
• {"criterion_text":"- Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis)."}
• {"criterion_text":"- Any known autoimmune disease."}
• {"criterion_text":"- Known HIV infection or any known type of congenital or iatrogenic immune deficiency (including IgA deficiency)."}
• {"criterion_text":"- Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities."}
• {"criterion_text":"- Children born prematurely, i.e., before 34 weeks of gestational age."}
• {"criterion_text":"- Children with an abnormally low or high weight for their age and height, if in the opinion of the Investigator, this would not allow safe completion of the clinical study."}
• {"criterion_text":"- Any known neoplasia or malignancy."}

Primary endpoints

• {"endpoint_text":"- Rate of wheezing/asthma-like episodes (WEs) during the 6 months of the Treatment period, defined as the number of WEs experienced by a subject during the 6month Treatment period.","definition_or_measurement_approach":"Defined as the number of WEs experienced by a subject during the 6-month Treatment period (count of wheezing/asthma‑like episodes per subject during treatment)."}

Secondary endpoints

• {"endpoint_text":"- Rate of severe WEs during the 6month Treatment period.","definition_or_measurement_approach":"Count/rate of severe wheezing/asthma‑like episodes experienced by each subject during the 6-month Treatment period."}
• {"endpoint_text":"- Rate of WE requiring OCS treatment during the 6-month Treatment period.","definition_or_measurement_approach":"Count/rate of wheezing/asthma‑like episodes during the 6-month Treatment period that required oral corticosteroid (OCS) treatment."}
• {"endpoint_text":"- Number of days with wheezing/asthma-like symptoms during the 6month Treatment period.","definition_or_measurement_approach":"Cumulative number of days with wheezing/asthma‑like symptoms recorded for each subject during the 6-month Treatment period."}
• {"endpoint_text":"- Safety, including AEs, SAEs, vital signs, and physical examination.","definition_or_measurement_approach":"Standard safety assessments during study including recording of adverse events (AEs), serious adverse events (SAEs), vital signs and physical examination findings over the Treatment, Observational and Whole study periods."}

Methods

• Flyer (K2_Recruitment material Flyer POL Polish) - printed recruitment material targeted to parents/guardians (Poland).
• Poster (K2_Recruitment material Poster POL Polish) - printed recruitment poster targeted to parents/guardians (Poland).
• Website (K2_Recruitment material Website POL Polish) - online recruitment material (Poland).
• Brochure (K1_Recruitment arrangements Brochure POL Polish) - informational brochure for parents/guardians (Poland).
• Dear Patient Letter (K2_Recruitment material Dear Patient Letter POL Polish) - direct communication to potential participants/guardians (Poland).
• Recruitment procedure description (K1_Recruitment arrangements Procedure Description POL) - procedural document describing recruitment arrangements (Poland).
• Consent Navigator (K2_Recruitment material Consent Navigator HUN Hungarian) - supportive material for consent process (Hungary).
• Other appreciation items and participation cards (various K2/L2 documents) - local participant materials (Poland, Hungary).
• ePRO materials (L2_Other subject information material ePRO HUN Hungarian) - electronic patient-reported outcome tools (Hungary).

Hungary

Earliest CTIS Part Ii Submission Date

31-05-2024

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

504

Number Of Sites

2

Number Of Participants

26

Poland

Earliest CTIS Part Ii Submission Date

10-06-2024

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

494

Number Of Sites

4

Number Of Participants

59

Primary sponsor

Full Name

OM Pharma SA

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Multiple CRO/operational responsibilities (codes: 11,12,13,5,6,9)

Third parties

• {"country":"United States","full_name":"Clario","duties_or_roles":"eCOA (Electronic Clinical Outcome Assessment) solution intended for the electronic data capture","organisation_type":"Industry"}
• {"country":"South Africa","full_name":"Ampath Clinical Trials, Ampath National Laboratories","duties_or_roles":"Analysis of total and specific IgE","organisation_type":"Industry"}
• {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Central Laboratory services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Reimbursement in Hungary","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Data Surveillance services","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"Trial Supply","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Alsinova Boulogne-Billancourt","duties_or_roles":"Regulatory activities (duty code provided)","organisation_type":"Industry"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Clinical systems (duty code provided)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Randomization","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"Other (duty code provided)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"South Africa","full_name":"Synexa Life Sciences (Pty) Ltd.","duties_or_roles":"Analysis of central lab samples","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Multiple CRO/operational responsibilities (codes: 11,12,13,5,6,9)","organisation_type":"Pharmaceutical company"}