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Trial Outcomes & Findings for Defining and Treating Depression-related Asthma (NCT NCT04617015)

NCT ID: NCT04617015

Last Updated: 2026-04-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

39 participants

Primary outcome timeframe

Baseline and 30 minutes

Results posted on

2026-04-23

Participant Flow

All subjects enrolled received ipratropium bromide

Participant milestones

Participant milestones
Measure
Ipratropium Bromide
All subjects will receive ipratropium bromide hydrofluoroalkane (HFA) and will have spirometry performed before and after ipratropium.
Overall Study
STARTED
39
Overall Study
COMPLETED
39
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Defining and Treating Depression-related Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ipratropium Bromide
n=39 Participants
All subjects will receive ipratropium bromide HFA and will have spirometry performed before and after ipratropium.
Age, Categorical
<=18 years
39 Participants
n=60 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=60 Participants
Age, Categorical
>=65 years
0 Participants
n=60 Participants
Age, Continuous
12.92 years
STANDARD_DEVIATION 3.27 • n=60 Participants
Sex: Female, Male
Female
19 Participants
n=60 Participants
Sex: Female, Male
Male
20 Participants
n=60 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=60 Participants
Race (NIH/OMB)
Asian
0 Participants
n=60 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=60 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=60 Participants
Race (NIH/OMB)
White
18 Participants
n=60 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=60 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=60 Participants
Children's Depression Inventory T-score
47 T-score
STANDARD_DEVIATION 9 • n=60 Participants
FEV1 %predicted
80.05 percent
STANDARD_DEVIATION 20.89 • n=60 Participants
Exhaled nitric oxide (FeNO)
44.62 ppb
STANDARD_DEVIATION 48.80 • n=60 Participants
Blood eosinophils
387.38 cells/mm^3
STANDARD_DEVIATION 298.15 • n=60 Participants
Specific allergen sensitization
3.06 positive skin tests
STANDARD_DEVIATION 3.08 • n=60 Participants
Serum Immunoglobulin E (IgE)
613.6 UI/ml
STANDARD_DEVIATION 696.6 • n=60 Participants
ATI Mood Score
7.95 units on a scale
n=60 Participants

PRIMARY outcome

Timeframe: Baseline and 30 minutes

Population: All subjects received ipratropium bromide. Bronchodilator response was compared to continuous variable of CDI T score to compare bronchodilator response to depressive symptoms

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

Outcome measures

Outcome measures
Measure
Ipratropium Bromide
n=39 Participants
All subjects will receive ipratropium bromide HFA and assess bronchodilator response to ipratropium bromide
FEV1 Percent Change Post-ipratropium
10.8 percent change
Interval -9.0 to 33.0

SECONDARY outcome

Timeframe: 30 minutes and 45 minutes

Population: 32 of the 39 enrolled subjects agreed to receive additional albuterol after ipratropium, and additional percent-change in FEV1 was assessed 15 minutes post-albuterol compared to the post-ipratropium FEV1

difference between lung function (FEV1) measurement from post ipratropium to 15 minutes post-albuterol This measure was calculated using the formula: (Post-albuterol value - post-ipratropium value) / post-ipratropium value x100

Outcome measures

Outcome measures
Measure
Ipratropium Bromide
n=32 Participants
All subjects will receive ipratropium bromide HFA and assess bronchodilator response to ipratropium bromide
FEV1 Percent Change Post-albuterol
8.9 percent change
Interval -7.0 to 45.0

Adverse Events

Ipratropium Bromide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Lehman

SUNY Buffalo

Phone: 716-323-0130

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place