Trial Outcomes & Findings for Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation (NCT NCT03780387)

Results Overview

Pre-challenge FEV1 is measured just prior to administration of the allergen challenge. FEV1 is measured at regular intervals for 10 hours after the challenge. \[(Lowest FEV1 value post-challenge - Pre-challenge FEV1 value)/(Pre-challenge FEV1 value)\]\*100

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

1 participants

Primary outcome timeframe

Pre-challenge to 10 hours post-challenge

Results posted on

2022-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Inhaled Allergen Challenge Inhalation of Felis Catus allergen in participants with documented allergic sensitization to cat hair. Control diluent followed by concentrations of Felis Catus allergen administered at 10-minute intervals starting with solutions of 0.31, 0.61, 1.22, 2.44, 4.89, 9.77, 19.5, 39, 78.13, 156.25, 312.5, and 625 BAU/mL via nebulizer until an FEV1 decline \>/= 20% reached.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inhaled Allergen Challenge n=1 Participants Felis Catus sensitive, mild asthmatics will undergo inhaled allergen challenge. Felis Catus: Inhalation of Felis Catus allergen in subjects allergic to Felis Catus
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 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	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-challenge to 10 hours post-challenge

Population: A single participant completed the cat allergen inhalation challenge.

Pre-challenge FEV1 is measured just prior to administration of the allergen challenge. FEV1 is measured at regular intervals for 10 hours after the challenge. \[(Lowest FEV1 value post-challenge - Pre-challenge FEV1 value)/(Pre-challenge FEV1 value)\]\*100

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Maximum Change in the Percentage of Forced Expiratory Volume in 1 Second (FEV1)	-21 percentage change in FEV1 Standard Deviation NA Standard deviation (SD) not calculated for 1 participant.

SECONDARY outcome

Timeframe: Baseline and 24 hours post- inhalation challenge

Population: Samples are typically batch processed and it was cost-prohibitive to run one participant's sample.

Participants will undergo a hypertonic saline induced sputum procedure at baseline (within \~2 weeks of the allergen challenge), and again at 24 hours following inhaled allergen challenge. IL-1β concentrations in the sputum will be determined via ELISA. In addition to assessing changes in IL-1β levels, we will determine if IL-1β levels are predictive of key asthma outcomes following inhaled allergen challenge (see outcomes 3-7).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-challenge and 24 hours post-challenge

Population: a single participant underwent inhaled cat allergen challenge.

Induced sputum obtained pre-challenge and again at 24 hours post-challenge will be assessed for cells. (% eosinophils post-challenge - %eosinophils pre-challenge)

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in the Percentage of Sputum Eosinophils	-0.16 percentage of eosinophils Standard Deviation NA SD not calculated for 1 participant.

SECONDARY outcome

Timeframe: Baseline and 24 hours post- inhalation challenge

Population: Samples are typically batch processed and it was cost-prohibitive to run one participant's sample.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-challenge to 10 hours post-challenge

Population: A single participant underwent inhaled challenge with cat hair allergen

FEV1 will be measured prior to administration of the inhaled allergen challenge. The maximum drop in FEV1 that occurs during the late phase (3-10 hours after challenge) will be determined.

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Number of Participants Who Experience a Late Phase Response (Fall in FEV1≥15%) to Inhaled Allergen	1 Participants

SECONDARY outcome

Timeframe: Baseline to 24 hours post-challenge

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. Negative values indicate decrease and positive values indicate increase in doubling. (methacholine PC20 post-challenge - methacholine PC20 pre-challenge).

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in Airway Hyperresponsiveness Measured by Difference in Methacholine Dose Required to Produce a ≥20% Fall in FEV1 (PC20)	2.5 mg/mL Standard Deviation NA SD not calculated for 1 participant.

SECONDARY outcome

Timeframe: Pre-challenge to 24 hours post-challenge

Population: A single participant underwent inhalation challenge with cat hair allergen.

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

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in Exhaled Nitric Oxide (eNO) Levels in Ppb	-4 parts per billion Standard Deviation NA SD not calculated for 1 participant.

SECONDARY outcome

Timeframe: Pre challenge 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

SECONDARY outcome

Timeframe: Pre challenge and immediately post challenge

Nasal fluid collected for analysis of cytokines IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration immediately post-challenge) - (cytokine concentration pre-challenge)\].

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-8	-14790.89 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-6	-11.54 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1alpha	22.12 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1 beta	-23.71 picograms/mL Standard Deviation NA SD not calculated for 1 participant.

SECONDARY outcome

Timeframe: Pre challenge and 7 hours post challenge

Nasal strip to collect cytokines IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration 7h post-challenge) - (cytokine concentration pre-challenge)\].

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-8	-16076.98 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-6	-21.78 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1a	24.52 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1b	4.74 picograms/mL Standard Deviation NA SD not calculated for 1 participant.

SECONDARY outcome

Timeframe: Pre challenge and 24 hours post challenge

Nasal strip to collect cytokine IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration 24h post-challenge) - (cytokine concentration pre-challenge)\].

Outcome measures

Outcome measures
Measure	Inhaled Allergen Challenge n=1 Participants Inhalation of cat hair allergen in participants with documented allergic sensitization to cat hair
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-8	-10763.58 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-6	7.09 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1a	70.14 picograms/mL Standard Deviation NA SD not calculated for 1 participant.
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid IL-1b	-21.21 picograms/mL Standard Deviation NA SD not calculated for 1 participant.

Adverse Events

Inhaled Allergen Challenge

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

Michelle Hernandez, MD

University of North Carolina at Chapel Hill

Phone: 919-843-5383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place