WithdrawnNot Applicable

The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children

Stopped: Due to few capacities 2011 to 2016 the study was withdrawn.

Germany0Started 2011-05

Plain-language summary

The aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. Over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. The investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.

Who can participate

Age range

3 Years – 5 Years

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: * informed consent * age 3 to 6 years * diagnosis asthma * pulmonary function: FEV1 (% pred.)≥ 70% * ability to carry out 2 reproducible flow volume loops * moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine) * more than 4 weeks interval since last infection * 8 hours washout period of Short Acting Beta Agonist * 1 week washout period of Ipratropium Bromide * 1 week washout period of Long Acting Beta Agonist * 4 weeks washout period of Systemic Corticosteroids * 4 weeks washout period of Leukotriene Antagonists Exclusion Criteria: * Age \< 3 and \> 6 Years * Pulmonary function test: FEV1 (% pred.) \< 70% * Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) * Incapability to perform spirometry * Current participation in another clinical trial

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

Change of severe bronchial hyperresponsiveness over time of five years.

Timeframe: five years

Trial details

NCT IDNCT01144910

SponsorJohann Wolfgang Goethe University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Intrinsic Asthma trials