Trial Outcomes & Findings for Eosinophilic Airway Inflammation and Mepolizumab (NCT NCT00802438)

Last Updated: 2019-04-10

Results Overview

Percent of eosinophils was determined in the bronchoalveolar lavage fluid collected from the participant after segmental allergen challenge. This was done via differential cell count using Hema-3 stain. Cell differentials were determined by counting a total of 1000 cells on two cytospin preparations. The percent eosinophils were done before and after administration of mepolizumab for a specified amount of time (up to 3 months of administration).

Recruitment status

COMPLETED

Study phase

Target enrollment

38 participants

Primary outcome timeframe

before and after up to 3 months of Mepo.

Results posted on

2019-04-10

Participant Flow

The recruitment period lasted two years (July 2008 through November 2010. Participants were recruited from our Recruitment Database, through local advertisements and the local allergy/asthma clinics.

After a participant signs a consent form, he/she goes through an extensive screening process that includes 4 research visits to the clinic before being assigned to their treatment. The inclusion/exclusion criteria for this study was long and many subjects screen failed prior to being assigned to a treatment.

Participant milestones

Participant milestones
Measure	Mepolizumab up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
Overall Study STARTED	38
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Mepolizumab up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
Overall Study Screen Failure	20
Overall Study Withdrawal by Subject	7
Overall Study Physician Decision	1

Baseline Characteristics

Eosinophilic Airway Inflammation and Mepolizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab n=38 Participants up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 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	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	3 Participants n=5 Participants
Race (NIH/OMB) White	34 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	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: before and after up to 3 months of Mepo.

Population: Participants had mild allergic asthma with a positive skin-prick test to house dust mite, ragweed, or a standardized extract of cat, a pre-180 4g albuterol FEV1 ≥70%, a post-albuterol FEV1 ≥ 80%; airway reversibility to albuterol (180 4g) ≥12% and/or airway hyper-reactivity to methacholine (PC20 ≤8 mg/ml).

Outcome measures

Outcome measures
Measure	Mepolizumab n=10 Participants up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4). Pre Mepolizumab	73 percent of bronchoalveolar eosinophils Interval 52.0 to 81.0
The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab Administration (Bronchoscopy #2 vs. Bronchoscopy #4). Post Mepolizumab	31 percent of bronchoalveolar eosinophils Interval 4.0 to 49.0

SECONDARY outcome

Timeframe: before and after up to 3 months of Mepo

IL-5 was measured via ELISA on bronchoalveolar lavage fluid before and after mepolizumab administration (up to 3 months of administration). Fluid was prepared in LowCross-Buffer to minimize potential matrix effects. A 1/2 dilution of 1X bronchoalveolar fluid was used for IL-5 detection. Data are expressed as pg/mL and are extrapolated to 1X.

Outcome measures

Outcome measures
Measure	Mepolizumab n=10 Participants up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab Pre Mepolizumab	409 pg/ml Interval 49.0 to 741.0
Effect of Mepolizumab on Bronchoalveolar Lavage Fluid Concentrations of IL-5 Cytokine Before and After Mepolizumab Post Mepolizumab	447 pg/ml Interval 66.0 to 1107.0

Adverse Events

Mepolizumab

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mepolizumab n=38 participants at risk up to 3 monthly doses of 750mg i.v. mepolizumab mepolizumab: up to three monthly doses of 750mg i.v. mepolizumab
Respiratory, thoracic and mediastinal disorders Laryngitis	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	10.5% 4/38 • Number of events 4 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
Musculoskeletal and connective tissue disorders Back pain	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
Immune system disorders Erythema	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
General disorders Pain	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
Skin and subcutaneous tissue disorders Rash on neck	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.
General disorders Fever	2.6% 1/38 • Number of events 1 • Each participant was followed anywhere between 36 weeks to 45 weeks depending on treatment path.

Additional Information

Gina Crisafi, BS

UW Madison

Phone: 608-265-4554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place