Trial Outcomes & Findings for Screening Inhaled Allergen Challenge for Dermatophagoides Farinae (NCT NCT03049111)

NCT ID: NCT03049111

Last Updated: 2022-10-18

Results Overview

Participants will undergo an inhaled allergen challenge to identify those with a measurable late phase response (LPR) to inhaled house dust mite allergen. Pre-challenge FEV1 will be measured prior to administration of the allergen challenge. The presence of an LPR will be defined as a decline in FEV1 of ≥10% from pre-challenge values 3-10 hours post-challenge.

• Recruitment status: TERMINATED
• Study phase: EARLY_PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: Pre-challenge to 3-10 hours post-challenge
• Results posted on: 2022-10-18

Participant Flow

Participant milestones

Measure	Inhaled Allergen Challenge Participants with mild asthma and sensitization to house dust mite (Dermatophagoides farinae) underwent inhalation challenge with house dust mite allergen. Control diluent followed by concentrations of house dust mite allergen (Dermatophagoides farinae) administered starting with solutions of 0.25, 0.50, 1.0, 2.0, 4.0, 8.0, 16, 32, 64, 125, 250, 500, 1000, and 2000 AU/mL via nebulizer until an FEV1 decline \>/= 20% reached.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening Inhaled Allergen Challenge for Dermatophagoides Farinae

Baseline characteristics by cohort

Measure	Inhaled Allergen Challenge n=14 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-challenge to 3-10 hours post-challenge

Participants will undergo an inhaled allergen challenge to identify those with a measurable late phase response (LPR) to inhaled house dust mite allergen. Pre-challenge FEV1 will be measured prior to administration of the allergen challenge. The presence of an LPR will be defined as a decline in FEV1 of ≥10% from pre-challenge values 3-10 hours post-challenge.

Outcome measures

Measure	Inhaled Allergen Challenge n=14 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Number of Participants With Decline in FEV1 ≥ 10% From Pre-challenge During 3-10 Hours Post-allergen Challenge	6 Participants

SECONDARY outcome

Timeframe: Pre-challenge to 24 hours post-challenge

Population: 11 participants had pre- and post-challenge sputum samples of sufficient quality for cytokine analysis. The remaining 3 participants were unable to produce a sputum sample or the sample produced was of inadequate quality for analysis.

Participants provided induced sputum pre-allergen challenge and again at 24 hours post-allergen challenge. IL-1β concentrations in the sputum will be determined via ELISA.

Outcome measures

Measure	Inhaled Allergen Challenge n=11 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Change in Concentration of IL-1β in Induced Sputum	37.5 picograms/mL Standard Deviation 102

SECONDARY outcome

Timeframe: Pre-challenge to 24 hours post- challenge

Population: Nine participants had pre and post-challenge sputum of sufficient quality for analysis of sputum cells; the remaining 5 either could not provide induced sputum or produced samples of inadequate quality for analysis of cell counts.

Percentage %eosinophils post-challenge minus pre-challenge values

Outcome measures

Measure	Inhaled Allergen Challenge n=9 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Change in Percentage of Eosinophils in Induced Sputum	18.1 percentage of sputum eosinophils Standard Deviation 22.1

SECONDARY outcome

Timeframe: Baseline and 24 hours post- inhalation challenge

Population: Although sample mucins were measured, due to sample integrity concerns no summary data were performed on these data.

Sputum mucins will be measured at baseline, and again at 24 hours following inhaled allergen challenge

Outcome measures

Measure	Inhaled Allergen Challenge n=14 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Mucins in Sputum	NA ug/mL Standard Deviation NA Although sample mucins were measured, due to sample integrity concerns no summary data were performed on these data.

SECONDARY outcome

Timeframe: Pre-challenge to 3-10 hours post-challenge

FEV1 will be measured prior to administration of the inhaled allergen challenge. The maximum change in FEV1 that occurs during the late phase (3-10 hours after challenge) will be determined. [(lowest FEV1 value recorded post-challenge) - (pre-challenge FEV1 value)/ pre-challenge FEV1 value] *100

Outcome measures

Measure	Inhaled Allergen Challenge n=14 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Maximum Percentage Change in FEV1 From Pre-challenge Values at 3-10 Hours Post-challenge	-10.7 percentage change in FEV1 Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline and 24 hours post-challenge

Population: Eleven participants had pre-challenge and post-challenge methacholine testing data available for analysis. Three participants did not have a post-challenge methacholine test performed because of reduced FEV1

Participants will undergo a methacholine challenge to assess airway hyper-responsiveness at baseline. Changes in methacholine reactivity from baseline to 24 hours post-allergen challenge will be determined.

Outcome measures

Measure	Inhaled Allergen Challenge n=11 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Change in Airway Hyperresponsiveness Measured by Difference in Methacholine Dose Required to Produce a ≥20% Fall in FEV1 (PC20)	-1.06 mg/mL Standard Deviation 2.77

SECONDARY outcome

Timeframe: pre-challenge to 24 hours post-challenge

eNO levels will be measured pre-challenge, and 24 hours post-challenge.

Outcome measures

Measure	Inhaled Allergen Challenge n=14 Participants Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Change in Exhaled Nitric Oxide (eNO) Levels	29.9 parts per billion Standard Deviation 32.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre and immediately post challenge

Population: Monitoring equipment were unavailable after being lost during transit and these data were not collected.

HRV with Spacelabs technology will be measured 24 hours pre and during inhalation challenge

Outcome measures

Outcome data not reported

Adverse Events

Inhaled Allergen Challenge

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inhaled Allergen Challenge n=14 participants at risk Participants with mild asthma and sensitization to house dust mite (Der f) underwent inhalation challenge with house dust mite allergen.
Respiratory, thoracic and mediastinal disorders Symptomatic bronchospasm	14.3% 2/14 • Number of events 2 • Adverse event data were collected from the time informed consent was obtained through 10 days post-challenge
Respiratory, thoracic and mediastinal disorders Increased asthma symptoms	21.4% 3/14 • Number of events 3 • Adverse event data were collected from the time informed consent was obtained through 10 days post-challenge
Musculoskeletal and connective tissue disorders Muscle strain	7.1% 1/14 • Number of events 1 • Adverse event data were collected from the time informed consent was obtained through 10 days post-challenge

Additional Information

Michelle Hernandez, MD

University of North Carolina at Chapel Hill

Phone: 919-843-5383

Email: michelle_hernandez@med.unc.edu

Results disclosure agreements

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