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

NCT03780387 | Terminated Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: 18-20061R01HL135235-01A1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma Atopic

Keywords

Felis Catus (cat)

Outcome Measures

Primary Outcomes (1)

• Maximum Change in the Percentage of Forced Expiratory Volume in 1 Second (FEV1)

  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

  Pre-challenge to 10 hours post-challenge

Secondary Outcomes (10)

• Levels of IL-1β in Induced Sputum

  Baseline and 24 hours post- inhalation challenge

• Change in the Percentage of Sputum Eosinophils

  Pre-challenge and 24 hours post-challenge

• Mucins in Sputum

  Baseline and 24 hours post- inhalation challenge

• Number of Participants Who Experience a Late Phase Response (Fall in FEV1≥15%) to Inhaled Allergen

  Pre-challenge to 10 hours post-challenge

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

  Baseline to 24 hours post-challenge

Study Arms (1)

Inhaled Allergen Challenge

EXPERIMENTAL

Felis Catus sensitive, mild asthmatics will undergo inhaled allergen challenge.

Biological: Felis Catus

Interventions

Felis Catus BIOLOGICAL

Inhalation of Felis Catus allergen in subjects allergic to Felis Catus

Also known as: Cat hair, Cat

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 FEV1/FVC (Forced Vital Capacity) 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 episodic or mild persistent asthma.
• Physician diagnosis of asthma
• Allergic sensitization to felis catus (cat hair) as confirmed by positive immediate skin prick test response
• Negative pregnancy test for females who are not s/p hysterectomy 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)

Katie Mills

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Catalase

Intervention Hierarchy (Ancestors)

Peroxidases; Oxidoreductases; Enzymes; Enzymes and Coenzymes

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, Chapel Hill

  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: December 17, 2018
• First Posted: December 19, 2018
• Study Start: April 16, 2019
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: October 18, 2022
• Results First Posted: July 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata Requests for access to individual participant data should be sent to bring44@email.unc.edu or carole.robinette@med.unc.edu. Access will be granted after a data access agreement has been signed with the University of North Carolina (UNC)

Locations

US (1)