Screening Inhaled Allergen Challenge for Dermatophagoides Farinae

NCT03049111 | Terminated Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 16-21311R01HL135235-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to identify Dermatophagoides farinae, or Der f, sensitive asthmatics who demonstrate a late phase asthmatic response after Der f inhalation. These subjects may be invited to participate in a planned future study investigating novel asthma treatments.

Conditions

Asthma

Keywords

Der F (House Dust Mite)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Decline in FEV1 ≥ 10% From Pre-challenge During 3-10 Hours Post-allergen 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.

  Pre-challenge to 3-10 hours post-challenge

Secondary Outcomes (6)

• Change in Concentration of IL-1β in Induced Sputum

  Pre-challenge to 24 hours post-challenge

• Change in Percentage of Eosinophils in Induced Sputum

  Pre-challenge to 24 hours post- challenge

• Mucins in Sputum

  Baseline and 24 hours post- inhalation challenge

• Maximum Percentage Change in FEV1 From Pre-challenge Values at 3-10 Hours Post-challenge

  Pre-challenge to 3-10 hours post-challenge

• Change in Airway Hyperresponsiveness Measured by Difference in Methacholine Dose Required to Produce a ≥20% Fall in FEV1 (PC20)

  Baseline and 24 hours post-challenge

Other Outcomes (1)

• Heart Rate Variability (HRV)

  Pre and immediately post challenge

Study Arms (1)

Inhaled Allergen Challenge

EXPERIMENTAL

Der f sensitive, mild asthmatic subjects will undergo inhaled allergen challenge

Biological: Der f

Interventions

Der f BIOLOGICAL

Inhalation of Der f in mild asthmatics who are sensitive to Der f.

Also known as: Dermatophagoides farinae, house dust mite

Inhaled Allergen Challenge

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range 18-45 years, inclusive
• FEV1 of at least 80% of predicted and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of at least 0.7 (without use of bronchodilator medications for 8 hours or long acting beta agonists for 24 hours), consistent with lung function of persons with no more than mild intermittent or mild persistent asthma.
• Physician diagnosis of asthma
• Positive methacholine inhalation challenge as performed in the separate screening protocol within the prior 12 months (defined as provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine)
• Allergic sensitization to house dust mite (D. farinae) as confirmed by positive immediate skin prick test response
• Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy or who have been amenorrheic for 12 months or more.
• Oxygen saturation of \>94% and blood pressure within the following limits: (Systolic between 150-90 mmHg, Diastolic between 90-60 mmHg).

You may not qualify if:

• Clinical contraindications:
• Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections or immunodeficiency.
• Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
• Exacerbation of asthma more than 2x/week which could be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
• Daily requirements for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma (not to include prophylactic use of albuterol prior to exercise).
• Viral upper respiratory tract infection within 4 weeks of challenge.
• Any acute infection requiring antibiotics within 6 weeks of exposure or fever of unknown origin within 6 weeks of challenge.
• Severe asthma
• Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
• Cigarette smoking \>1 pack per month
• Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
• Allergy/sensitivity to study drugs or their formulations
• Known hypersensitivity to methacholine or to other parasympathomimetic agents
• History of intubation for asthma
• Unwillingness to avoid coffee, tea, cola drinks, chocolate, or other foods containing caffeine after midnight on the days that methacholine challenge testing is to be performed.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Results Point of Contact

• Title: Michelle Hernandez, MD
• Organization: University of North Carolina at Chapel Hill

michelle_hernandez@med.unc.edu

919-843-5383

Study Officials

• Michelle Hernandez, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 9, 2017
• Study Start: January 29, 2018
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: October 18, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)