Early Phase 1
N=39
Defining and Treating Depression-related Asthma
Asthma · Depression · Childhood Asthma
Bottom Line
View on ClinicalTrials.gov: NCT04617015 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: FEV1 Percent Change Post-ipratropium — 10.8 percent change — p=0.032
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ipratropium Bromide (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 Percent Change Post-ipratropium |
10.8 | 0.032 sig |
| SECONDARY FEV1 Percent Change Post-albuterol |
8.9 | — |
Summary
Depression is seen more often in people with asthma, and may lead to increased development and severity of asthma.
This study will investigate whether children with depression and asthma have less allergic disease and less inflammation than children with asthma who do not have symptoms of depression.
The study will also investigate whether the lungs of children with depression and asthma respond to an anticholinergic inhaler called ipratropium more than the lungs of non-depressed asthmatic children.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of asthma
- Decreased lung volumes for age/height/race (FEV1 <80% predicted or ratio of FEV1 to forced vital capacity (FVC) < 85%) on day of study visit assessed by spirometry.
Exclusion Criteria
- Severely developmentally delayed patients, or those who suffer from other severe cognitive impairment not allowing them to perform spirometry or participate in study instruments.
- Patients who are pregnant or nursing.
- Patients with significant cardiopulmonary disease other than asthma, including cystic fibrosis, alpha-1-antitrypsin deficiency, interstitial lung disease, tracheo-/bronchomalacia, or cyanotic congenital cardiac defect.
- Patients with glaucoma, myasthenia gravis, or bladder neck obstruction (anticholinergics can worsen these conditions).
- Patients currently taking another anticholinergic medication
Data sourced from ClinicalTrials.gov (NCT04617015). 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.