New asthma treatment for kids who Don't respond to standard steroids?
NCT ID NCT04990167
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a drug called tiotropium works as well as inhaled steroids for children aged 6 to 11 with mild asthma that is not linked to allergies. Many children with non-allergic asthma do not respond well to steroids, so researchers wanted to see if tiotropium alone could be a safer option. The study was a small pilot with 11 children, but it was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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11 people
The number who actually took part.
- Started
-
Jan 2022
- Finished
-
Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 11 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Children ages 6 to 11 years with controlled mild nonatopic persistent physician diagnosed asthma 1. Non-atopic asthma: absence of a positive SPT to inhaled aeroallergens or negative specific IgE to a common regional allergen panel; historical serum IgE less than 200 IU/ml; historical serum eosinophils less than 350 cells per microliter (cells/mcL); no history of eczema; no history of allergic rhinitis; no history of food allergy 2. Physician-diagnosed asthma: positive family history, recurrent asthma symptoms, bronchodilator responsiveness, and evidence of obstruction. 3. Mild persistent asthma: current treatment with as-needed albuterol or low-dose ICS or daily montelukast (Step 2 therapy) 4. Controlled asthma: Childhood Asthma Control Test score \>19 2. Pre-bronchodilator FEV1 ≥ 80% of predicted Exclusion Criteria: 1. Oral corticosteroid use in the past 6 weeks 2. Use of ICS in combination with long-acting beta agonist or montelukast 3. History of life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years 4. Respiratory tract infection within the past 4 weeks 5. Any other chronic diseases or medical conditions (other than asthma) that in the opinion of the investigator would prevent participation in a trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nemours Specialty Care
Jacksonville, Florida, 32207, United States
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