Phase 3
N=120
Efficacy and Safety Evaluation in Recurrent Wheezing Attacks
Bronchospasm; Bronchiolitis · Bronchospasm; Bronchitis
Bottom Line
View on ClinicalTrials.gov: NCT01734811 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Sep 2020
Primary outcome: Primary: Number of Recurrent Bronchospasm (Wheezing Attacks) — 299; 176 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Biological vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Inmunotek S.L.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Recurrent Bronchospasm (Wheezing Attacks) |
299; 176 | — |
| SECONDARY Duration (Days) of Wheezing Attacks (WA) |
7.9; 6.0 | — |
| SECONDARY Time Until Appearance of First WA |
5.0; 41.0 | — |
| SECONDARY Number of Days With Wheezing Attacks During the Study |
42.0; 19.2 | — |
| SECONDARY Number of Patients With Recurrent WA During the Study |
45; 36 | — |
| SECONDARY Symptom Score During Wheezing Attacks |
155.0; 80.0 | — |
| SECONDARY Medication Score During WA |
424.0; 164.0 | — |
| SECONDARY Overall Symptom Score |
421.0; 276.5 | — |
| SECONDARY Overall Medication Score |
1043.5; 618.5 | — |
Summary
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.
Eligibility 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 (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
Data sourced from ClinicalTrials.gov (NCT01734811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.