Trial Outcomes & Findings for Role of the Isomerase Pin-1 in the Development and Treatment of Asthma (NCT NCT01691612)

Last Updated: 2017-07-03

Results Overview

Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge: Eosinophils post-challenge change from pre-challenge is reported: absolute change = \[eosinophils post (%) - eosinophils pre (%)\]

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

from baseline to 48 hours

Results posted on

2017-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	D. Pteronyssinus Allergens Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Overall Study STARTED	14
Overall Study First Visit (Allergen Challenge)	8
Overall Study Second Visit (Bronchoscopy)	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	D. Pteronyssinus Allergens Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Overall Study deemed ineligible after 1st visit	6
Overall Study Adverse Event	1

Baseline Characteristics

Role of the Isomerase Pin-1 in the Development and Treatment of Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	D. Pteronyssinus Allergens n=8 Participants Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24.9 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 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	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: from baseline to 48 hours

Outcome measures

Outcome measures
Measure	D. Pteronyssinus Allergens n=7 Participants Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours	82.11 percent of white blood cells Interval 0.24 to 88.51

SECONDARY outcome

Timeframe: from baseline to 48 hours

Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: \[100% \* ((Post-Pre)/Pre)\]

Outcome measures

Outcome measures
Measure	D. Pteronyssinus Allergens n=7 Participants Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours	-64.3 percent change Interval -100.0 to 50.0

SECONDARY outcome

Timeframe: from baseline to 48 hours

Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: \[100% \* ((Post-Pre)/Pre)\]

Outcome measures

Outcome measures
Measure	D. Pteronyssinus Allergens n=7 Participants Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours	-82.4 percent change Interval -89.3 to -5.9

SECONDARY outcome

Timeframe: from baseline to 48 hours

Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours

Outcome measures

Outcome measures
Measure	D. Pteronyssinus Allergens n=7 Participants Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours	3 percent of white blood cells Interval -5.0 to 19.0

Adverse Events

D. Pteronyssinus Allergens

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	D. Pteronyssinus Allergens n=14 participants at risk Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
Respiratory, thoracic and mediastinal disorders bronchitis	7.1% 1/14 • Number of events 1
Immune system disorders Allergic reaction	7.1% 1/14 • Number of events 2
General disorders Headache	7.1% 1/14 • Number of events 1
Gastrointestinal disorders Nausea	28.6% 4/14 • Number of events 4
Respiratory, thoracic and mediastinal disorders increased asthma symptoms	7.1% 1/14 • Number of events 1

Additional Information

Elliot Israel, M.D.

Brigham & Women's Hospital

Phone: 617-732-8110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place