CompletedPhase 3

Efficacy and Safety Evaluation in Recurrent Wheezing Attacks

Spain120 participantsStarted 2012-10

Plain-language 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.

Who can participate

Age range

12 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Recurrent Bronchospasm (Wheezing Attacks)

Timeframe: 12 months

Trial details

NCT IDNCT01734811

SponsorInmunotek S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05

Results submitted2020-05-28

View on ClinicalTrials.gov More Bronchospasm; Bronchiolitis trials

Who can participate

Age range

12 Months – 36 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.