Comparing Tiotropium and Inhaled Corticosteroids for Children with Nonatopic Asthma
Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study
PHASE2 · Nemours Children's Clinic · NCT04990167
This study is testing if a medication called Tiotropium can help children aged 6 to 11 with nonatopic asthma feel better compared to the usual inhaled steroids they often use.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Nemours Children's Clinic (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04990167 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of Tiotropium Bromide compared to inhaled corticosteroids (ICS) in children aged 6 to 11 years with nonatopic persistent asthma. The study aims to address the limited treatment options available for this group, as they often respond poorly to ICS. Participants will be assessed for asthma control and exacerbation rates over the course of the study. The research seeks to identify alternative treatment strategies for children who do not benefit from standard ICS therapy.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 11 years with controlled mild nonatopic persistent asthma.
Not a fit: Patients with atopic asthma or those who have used oral corticosteroids or ICS in combination with other medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for children with nonatopic asthma, potentially improving their asthma control and quality of life.
How similar studies have performed: While there is limited research specifically targeting nonatopic asthma in children, studies on alternative treatments for asthma have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jacksonville, Florida
- Nemours Specialty Care — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Gerardo A Vazquez Garcia, MD — Nemours
- Study coordinator: Jennifer Gafford, RN
- Email: Jennifer.Gafford@nemours.org
- Phone: 904-697-3804
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma in Children, Nonatopic