Asthma AtopicEarly Phase 1NCT03780387
Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation
A Early Phase 1 study testing Felis Catus in people with Asthma Atopic, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma Atopic
- What is being tested?
- Felis Catus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 11 Nov 2019
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 33Show fewer
- 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.
- Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch, condoms).
- Pregnancy or nursing a baby. Female volunteers will be asked to use effective birth control (stable regimen of hormonal contraceptive use for at least 3 months, intrauterine device placement, tubal ligation or endometrial ablation for at least 3 months through at least one week after study completion) and will provide a urine sample to test for pregnancy on study days. If the test is positive or the subject has reason to believe she may be pregnant, she will be dismissed from the study. Women who have been amenorrheic for 12 months may participate. Male volunteers will be asked to use condoms for the duration of the study through at least one week after study completion.
- Usage of the following medications:
- Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
- Subjects who are prescribed daily inhaled corticosteroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirlukast) will be required to discontinue these medications at least 2 weeks prior to their screening visit.
- Use of daily theophylline within the past month.
- Daily requirement 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).
- Use of any immunosuppressant therapy within the preceding 12 months will be reviewed by the study physician.
- Receipt of Live Attenuated Influenza Vaccine (LAIV), also known as FluMist®, or any other live viral vaccine within the prior 30 days, or any vaccine for at least 5 days
- Use of beta blocking medications
- Antihistamines in the 5 days prior to allergen challenge
- Routine use of NSAIDs, including aspirin.
- Physical/laboratory indications:
- Abnormalities on lung auscultation
- Temperature >37.8°C
- Oxygen saturation of <94%
- Systolic BP>150 mmHg or <90 mmHg or diastolic BP>90 mmHg or <60 mmHg
- Inability or unwillingness of a participant to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Asthma is an increasingly common chronic illness among children and adults, and allergen exposure is among the most common triggers for asthma exacerbations. Exacerbations of allergic asthma are characterized by an early phase response (EPR), mediated by release of preformed mediators like histamine from mast cells, and a late phase response (LPR) 3-7 hours later mediated by chemokines and cytokines that attract leukocytes such as neutrophils and eosinophils to the airways, increase mucus production, trigger airway smooth muscle contraction, and result in airway constriction and airway hyperreactivity (AHR). The LPR does not occur in the absence of an EPR. The LPR is thought to be predominantly responsible for the symptoms associated with acute exacerbations of allergic asthma and is often used as the measure of efficacy in trials of asthma therapeutics.
This group has taken a particular interest in targeting an inflammatory cytokine, Interleukin-1β, involved in both the early and late phase asthmatic responses to inhaled allergen in allergic asthmatics. In the lung, interleukin 1 beta (IL-1β) is produced by numerous cell types (including epithelial cells, macrophages, neutrophils, eosinophils, and mast cells), where it signals through its receptor to induce transcription of pro-inflammatory genes (17-19). IL-1β is increased in bronchoalveolar lavage fluid from persons with symptomatic asthma vs. those with asymptomatic asthma; likewise, immunohistochemistry of bronchial biopsies of allergic asthmatics reveal increased expression of IL-1β in both bronchial epithelial cells and macrophages.
In order to better understand the role of IL-1β in allergen-induced airway inflammation, induced sputum will be obtained to determine if higher baseline sputum IL-1β concentrations or larger increases in IL-1β following allergen challenge impact non-specific airway hyperresponsiveness (via methacholine challenge), sputum granulocyte recruitment (neutrophil and eosinophil counts and exhaled nitric oxide (eNO), a marker of airway eosinophilia), or changes in expression of inflammatory or allergy-related genes. To this last point, little is known about the mechanisms contributing to response patterns in allergic asthmatics undergoing allergen challenge. Changes in gene expression occurring during the window of time between the EPR and LPR, as these expression changes may dictate whether or not a LPR occurs or to what extent it occurs.
The goal of this screening protocol is to identify subjects who exhibit both an EPR and LPR and who will be eligible for enrollment in the yet to be developed IL-1β protocols. Subjects will undergo a baseline methacholine challenge to establish reactivity, then allergen exposure, followed 24 hours later by methacholine challenge.
- Conditions
- Asthma Atopic
- Being tested
- Felis Catus
- Keywords
- Felis Catus (cat)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felis CatusBiological
Also called Cat hair, Cat
Inhalation of Felis Catus allergen in subjects allergic to Felis Catus
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Allergen Challenge | Experimental | Felis Catus sensitive, mild asthmatics will undergo inhaled allergen challenge. Receives: Biological: Felis Catus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-challenge to 10 hours post-challenge
Secondary outcomes (10)
Levels of IL-1β in Induced Sputum
Participants will undergo a hypertonic saline induced sputum procedure at baseline (within ~2 weeks of the allergen challenge), and again at 24 hours following inhaled allergen challenge. IL-1β concentrations in the sputum will be determined via ELISA. In addition to assessing changes in IL-1β levels, we will determine if IL-1β levels are predictive of key asthma outcomes following inhaled allergen challenge (see outcomes 3-7).
Measured: Baseline and 24 hours post- inhalation challenge
Change in the Percentage of Sputum Eosinophils
Induced sputum obtained pre-challenge and again at 24 hours post-challenge will be assessed for cells. (% eosinophils post-challenge - %eosinophils pre-challenge)
Measured: Pre-challenge and 24 hours post-challenge
Mucins in Sputum
Sputum mucins will be measured at baseline, and again at 24 hours following inhaled allergen challenge
Measured: Baseline and 24 hours post- inhalation challenge
Number of Participants Who Experience a Late Phase Response (Fall in FEV1≥15%) to Inhaled Allergen
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.
Measured: 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)
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).
Measured: Baseline to 24 hours post-challenge
Change in Exhaled Nitric Oxide (eNO) Levels in Ppb
eNO levels will be measured pre-challenge, and 24 hours post-challenge. (eNO value post-challenge - eNO value pre-challenge)
Measured: Pre-challenge to 24 hours post-challenge
Heart Rate Variability (HRV)
HRV with Spacelabs technology will be measured 24 hours pre and during inhalation challenge
Measured: Pre challenge and immediately post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
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)].
Measured: Pre challenge and immediately post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
Nasal strip to collect cytokines IL-8, IL-6, IL-1alpha, IL-1 beta. [(Cytokine concentration 7h post-challenge) - (cytokine concentration pre-challenge)].
Measured: Pre challenge and 7 hours post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
Nasal strip to collect cytokine IL-8, IL-6, IL-1alpha, IL-1 beta. [(Cytokine concentration 24h post-challenge) - (cytokine concentration pre-challenge)].
Measured: Pre challenge and 24 hours post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start16 Apr 2019
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Why it stopped: Terminated due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma AtopicStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle Hernandez, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780387
- Sponsor's protocol ID
- 18-2006
- Other IDs
- 1R01HL135235-01A1
- Status last verified
- Jun 2022
- First submitted
- 17 Dec 2018
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Allergic Asthmatics Reactive to Felis Catus (Cat Hair) Allergen Inhalation
- ClinicalTrials.gov ID
- NCT03780387
- Acronym / sponsor ID
- 18-2006
- Conditions
- Asthma Atopic
- Keywords
- Felis Catus (cat)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to COVID-19 pandemic.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 14 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is an increasingly common chronic illness among children and adults, and allergen exposure is among the most common triggers for asthma exacerbations. Exacerbations of allergic asthma are characterized by an early phase response (EPR), mediated by release of preformed mediators like histamine from mast cells, and a late phase response (LPR) 3-7 hours later mediated by chemokines and cytokines that attract leukocytes such as neutrophils and eosinophils to the airways, increase mucus production, trigger airway smooth muscle contraction, and result in airway constriction and airway hyperreactivity (AHR). The LPR does not occur in the absence of an EPR. The LPR is thought to be predominantly responsible for the symptoms associated with acute exacerbations of allergic asthma and is often used as the measure of efficacy in trials of asthma therapeutics.
This group has taken a particular interest in targeting an inflammatory cytokine, Interleukin-1β, involved in both the early and late phase asthmatic responses to inhaled allergen in allergic asthmatics. In the lung, interleukin 1 beta (IL-1β) is produced by numerous cell types (including epithelial cells, macrophages, neutrophils, eosinophils, and mast cells), where it signals through its receptor to induce transcription of pro-inflammatory genes (17-19). IL-1β is increased in bronchoalveolar lavage fluid from persons with symptomatic asthma vs. those with asymptomatic asthma; likewise, immunohistochemistry of bronchial biopsies of allergic asthmatics reveal increased expression of IL-1β in both bronchial epithelial cells and macrophages.
In order to better understand the role of IL-1β in allergen-induced airway inflammation, induced sputum will be obtained to determine if higher baseline sputum IL-1β concentrations or larger increases in IL-1β following allergen challenge impact non-specific airway hyperresponsiveness (via methacholine challenge), sputum granulocyte recruitment (neutrophil and eosinophil counts and exhaled nitric oxide (eNO), a marker of airway eosinophilia), or changes in expression of inflammatory or allergy-related genes. To this last point, little is known about the mechanisms contributing to response patterns in allergic asthmatics undergoing allergen challenge. Changes in gene expression occurring during the window of time between the EPR and LPR, as these expression changes may dictate whether or not a LPR occurs or to what extent it occurs.
The goal of this screening protocol is to identify subjects who exhibit both an EPR and LPR and who will be eligible for enrollment in the yet to be developed IL-1β protocols. Subjects will undergo a baseline methacholine challenge to establish reactivity, then allergen exposure, followed 24 hours later by methacholine challenge.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled Allergen Challenge | Experimental | Biological: Felis CatusFelis Catus sensitive, mild asthmatics will undergo inhaled allergen challenge. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Felis CatusAlso: Cat hair, CatInhalation of Felis Catus allergen in subjects allergic to Felis Catus | Biological | Inhaled Allergen Challenge |
Primary outcome
Maximum Change in the Percentage of Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 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
10 secondary outcomes
Levels of IL-1β in Induced Sputum
Time frame: Baseline and 24 hours post- inhalation challenge
Change in the Percentage of Sputum Eosinophils
Time frame: Pre-challenge and 24 hours post-challenge
Mucins in Sputum
Time frame: Baseline and 24 hours post- inhalation challenge
Number of Participants Who Experience a Late Phase Response (Fall in FEV1≥15%) to Inhaled Allergen
Time frame: 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)
Time frame: Baseline to 24 hours post-challenge
Change in Exhaled Nitric Oxide (eNO) Levels in Ppb
Time frame: Pre-challenge to 24 hours post-challenge
Heart Rate Variability (HRV)
Time frame: Pre challenge and immediately post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
Time frame: Pre challenge and immediately post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
Time frame: Pre challenge and 7 hours post challenge
Change in Concentration of Inflammatory Cytokines in Nasal Epithelial Lining Fluid
Time frame: Pre challenge and 24 hours post challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Hernandez, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Felis Catus in people with Asthma Atopic, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Change in the Percentage of Forced Expiratory Volume in 1 Second (FEV1) (time frame: Pre-challenge to 10 hours post-challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.