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NCT03780387

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

Terminated EARLY_PHASE1 Results posted Last updated 18 October 2022
What this trial tests

EARLY_PHASE1 trial testing Felis Catus in Asthma Atopic in 1 participant. Terminated before completion.

Timeline
16 April 2019
Primary endpoint
11 November 2019
11 November 2019

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseEARLY_PHASE1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment1
Start date16 April 2019
Primary completion11 November 2019
Estimated completion11 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 45, any sex, with Asthma Atopic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Change in the Percentage of Forced Expiratory Volume in 1 Second (FEV1) Primary · Pre-challenge to 10 hours post-challenge

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

GroupValue95% CI
Inhaled Allergen Challenge-21± NA
Change in the Percentage of Sputum Eosinophils Secondary · Pre-challenge and 24 hours post-challenge

Induced sputum obtained pre-challenge and again at 24 hours post-challenge will be assessed for cells. (% eosinophils post-challenge - %eosinophils pre-challenge)

GroupValue95% CI
Inhaled Allergen Challenge-0.16± NA
Number of Participants Who Experience a Late Phase Response (Fall in FEV1≥15%) to Inhaled Allergen Secondary · Pre-challenge to 10 hours post-challenge

FEV1 will be measured prior to administration of the inhaled allergen challenge. The maximum drop in FEV1 that occurs during the late phase (3-10 hours after challenge) will be determined.

GroupValue95% CI
Inhaled Allergen Challenge1
Change in Airway Hyperresponsiveness Measured by Difference in Methacholine Dose Required to Produce a ≥20% Fall in FEV1 (PC20) Secondary · Baseline to 24 hours post-challenge

Participants will undergo a methacholine challenge to assess airway hyper-responsiveness at baseline. Changes in methacholine reactivity from baseline to 24 hours post-allergen challenge will be determined. Negative values indicate decrease and positive values indicate increase in doubling. (methacholine PC20 post-challenge - methacholine PC20 pre-challenge).

GroupValue95% CI
Inhaled Allergen Challenge2.5± NA
Change in Exhaled Nitric Oxide (eNO) Levels in Ppb Secondary · Pre-challenge to 24 hours post-challenge

eNO levels will be measured pre-challenge, and 24 hours post-challenge. (eNO value post-challenge - eNO value pre-challenge)

GroupValue95% CI
Inhaled Allergen Challenge-4± NA
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid Secondary · Pre challenge and immediately post challenge

Nasal fluid collected for analysis of cytokines IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration immediately post-challenge) - (cytokine concentration pre-challenge)\].

IL-8
GroupValue95% CI
Inhaled Allergen Challenge-14790.89± NA
IL-6
GroupValue95% CI
Inhaled Allergen Challenge-11.54± NA
IL-1alpha
GroupValue95% CI
Inhaled Allergen Challenge22.12± NA
IL-1 beta
GroupValue95% CI
Inhaled Allergen Challenge-23.71± NA
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid Secondary · Pre challenge and 7 hours post challenge

Nasal strip to collect cytokines IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration 7h post-challenge) - (cytokine concentration pre-challenge)\].

IL-8
GroupValue95% CI
Inhaled Allergen Challenge-16076.98± NA
IL-6
GroupValue95% CI
Inhaled Allergen Challenge-21.78± NA
IL-1a
GroupValue95% CI
Inhaled Allergen Challenge24.52± NA
IL-1b
GroupValue95% CI
Inhaled Allergen Challenge4.74± NA
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid Secondary · Pre challenge and 24 hours post challenge

Nasal strip to collect cytokine IL-8, IL-6, IL-1alpha, IL-1 beta. \[(Cytokine concentration 24h post-challenge) - (cytokine concentration pre-challenge)\].

IL-8
GroupValue95% CI
Inhaled Allergen Challenge-10763.58± NA
IL-6
GroupValue95% CI
Inhaled Allergen Challenge7.09± NA
IL-1a
GroupValue95% CI
Inhaled Allergen Challenge70.14± NA
IL-1b
GroupValue95% CI
Inhaled Allergen Challenge-21.21± NA

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03780387.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing