Defining and Treating Depression-related Asthma

NCT04617015 | Completed Early Phase 1 Results FDA Drug

• 2 other identifiers: STUDY00000774UL1TR001412
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Asthma; Asthma; Depression

Keywords

asthma; depression; anticholinergic therapy

Outcome Measures

Primary Outcomes (1)

• FEV1 Percent Change Post-ipratropium

  difference between lung function (FEV1) measurement from baseline to 30 minutes post ipratropium This measure was calculated using the formula: (Post-ipratropium value - baseline value) / baseline value x100

  Baseline and 30 minutes

Secondary Outcomes (1)

• FEV1 Percent Change Post-albuterol

  30 minutes and 45 minutes

Study Arms (1)

Ipratropium bromide

EXPERIMENTAL

All subjects will receive ipratropium bromide hydrofluoroalkane (HFA) inhaler and will have spirometry performed before and after ipratropium.

Drug: Ipratropium Bromide

Interventions

Ipratropium Bromide DRUG

All subjects receive inhaled ipratropium once with measurement of spirometry before and after. Bronchodilator response of subjects with depression is compare to that of subjects without depression.

Ipratropium bromide

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

MeSH Terms

Conditions

Asthma; Depression

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Heather Lehman
• Organization: SUNY Buffalo

hkm@buffalo.edu

716-323-0130

Study Officials

• Heather K Lehman, MD

  SUNY at Buffalo School of Medicine and Biomedical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Pediatrics

Model Details: Children with asthma and depression versus children with asthma without depression are compared for presence of allergies, airway inflammation, and response to bronchodilation with ipratropium.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: November 5, 2020
• Study Start: September 9, 2016
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)