Trials Sponsors Conditions Drugs Pricing

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
+5 more secondary outcomes

Study Arms (1)

Inhaled Allergen Challenge

EXPERIMENTAL

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

Biological: Felis Catus

Interventions

Felis CatusBiological

Inhalation of Felis Catus allergen in subjects allergic to Felis Catus

Also known as: Cat hair, Cat

Inhaled Allergen Challenge

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

University of North Carolina, Chapel Hill
Otherlead
National Heart, Lung, and Blood Institute (NHLBI)
NIHcollaborator

Study Sites (1)

Katie Mills

Chapel Hill, North Carolina, 27599, United States

MeSH Terms

Interventions

Catalase

Intervention Hierarchy (Ancestors)

PeroxidasesOxidoreductasesEnzymesEnzymes and Coenzymes

Results Point of Contact

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

Study Officials

Michelle Hernandez, MD
University of North Carolina, Chapel Hill
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

1 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.
+18 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Inhaled Allergen Challenge

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Inhaled Allergen Challenge

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations