Recurrent bronchospasm MedDRA version: 14.1 Level: PT Classification code 10006482 Term: Bronchospasm System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Inmunotek S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects whose parents /legal representative have given written informed consent. - Both gender - Subject up to 36 months of age. - Subjects with recurrent bronchospasms ; 3 or more exacerbations in the last 12 months Are the trial subjects under 18? yes Number of subjects for this age range: 108 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects whose parents/legal representative have not given written informed consent. - Subjects out of aged range - Subjects with malignancies or chemotherapy treatment - Subjects included in another clinical trial in the last 12 months. - Subject in immunosuppressive or immunostimulatory treatment - Subjects who have received iv gamma globulin in the past 12 months. - Subjects with recurrent respiratory infections - Subjects diagnosed with candidiasis or fungal recurrent infections. - Subjects diagnosed with malabsorption syndrome - Subjects with clinical allergy tocommon aeroallergens in the geographical area. - Subjects with hepatitis virus infections, HIV and tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ? Shortening of bronchospasm episodes ? Rate of episodes ? Reduction in the antibiotics, oral corticosteroids, use of rescue bronchodilators and inhaled corticosteroid consumption ? Respiratory infections episodes reduction ? Direct costs: unscheduled visits to health center, emergency service visits, days of hospitalization and cost thereof, complementary tests, phone calls to the doctor or pediatrician ? Indirect costs: absenteeism from nursery, caregivers to the child at home and during hospital admissions. ? NNT to prevent one episode of bronchospasm ? Free day?s symptom percentage during the trial. ? Free day?s medication percentage of during the trial ? Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration;Main Objective: To evaluate the efficacy of a bacterial vaccine administered sublingually to prevent episodes of bronchospasm in patients with bronchospasm episodes induced by recurrent respiratory tract infections, compared with a placebo group;Primary end point(s): The primary endpoint is to evaluate the efficacy of a bacterial vaccine, sublingally administered to prevent bronchospams episodes in subjects with bronchospam episodes compared with a placebo group;Timepoint(s) of evaluation of this end point: The baseline and the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Shortening of bronchospasm episodes ? Rate of episodes ? Reduction in the antibiotics, oral corticosteroids, use of rescue bronchodilators and inhaled corticosteroid consumption ? Respiratory infections episodes reduction ? Direct costs: unscheduled visits to health center, emergency service visits, days of hospitalization and cost thereof, complementary tests, phone calls to the doctor or pediatrician ? Indirect costs: absenteeism from nursery, caregivers to the child at home and during hospital admissions. ? NNT to prevent one episode of bronchospasm ? Free day?s symptom percentage during the trial. ? Free day?s medication percentage of during the trial ? Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration;Timepoint(s) of evaluation of this end point: - Baseline - Visit 1 (2 months after baseline) - Visit 2 (2 months after visit 1) - Visit 3 (2 months after visit 2) - Visit 4 (3 months after visit 3) - Visit 5 (3 months after visit 4) | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas; Medical Director
Inmunotek S.L.
Outcome results
None listed