Efficacy and Safety Evaluation in Recurrent Wheezing Attacks (MV130)

Inmunotek

Status and phase: Completed; Phase 3

Conditions: Bronchospasm; Bronchitis; Bronchospasm; Bronchiolitis

Treatments: Biological: Biological vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01734811

MV130-SLG-002

2012-002450-24 (EudraCT Number)

Details and patient eligibility

About

The study will be conducted in two hospitals of the same geographic area. It will be included children <3-years-old with recurrent wheezing attacks, confirmed by the review of the medical records, in the previous 12 months or a shorter time for those younger than one year.

Full description

This randomized, double-blind, placebo-controlled, parallel-group study will included 120 children <3 years old with ≥3 episodes of wheezing during the previous year. They will receive active treatment or placebo for six months. The main outcome will be the number of wheezing attacks during one year. Other outcomes were duration and severity of wheezing attacks , symptom and medication scores, and use of health resources.

Enrollment: 120 patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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 (wheezing attacks); 3 or more exacerbations in the last 12 months

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 diagnosed with candidiasis or fungal recurrent infections.
• Subjects diagnosed with malabsorption syndrome
• Subjects with clinical allergy to common aeroallergens in the geographical area.
• Subjects with hepatitis virus infections, HIV and tuberculosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The subjects will receive daily placebo spray (2 puff of 100 µL) for 6 months, followed by other 6 months of observation

Treatment:

Biological: Biological vaccine

Biological vaccine

Experimental group

Description:

The subjects will receive daily biological vaccines pray (2 puff of 100 µL) of for 6 months, followed by other 6 months of observation

Treatment:

Biological: Biological vaccine