Tobacco SmokingPhase 1Kitty NoseNCT03031145
Investigation of the Impact of Smoking Status on Allergen-induced Nasal Airway Inflammation Using a Cat Hair (Felis Domesticus) Extract Nasal Allergen Challenge Model
A Phase 1 study testing Felis Domesticus in people with Tobacco Smoking and Healthy Participants, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of felis domesticus, or cat, extract in e-cigarette users, cigarette smokers, and non-smokers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Healthy Participants, E-cigarette Smokers
- What is being tested?
- Felis Domesticus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2017to 4 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females age 18-50 years
- Specific allergy to cat hair Felis domesticus confirmed by positive immediate skin test response
- Subjects may be enrolled with mild asthma if a Forced Expiratory Volume in 1 second (FEV1) of at least 80% of predicted and a Forced Expiratory Volume in 1 second to Forced Vital Capacity (FVC) ratio (FEV1/FVC ratio) of at least .75 (without use of bronchodilator medications for 12 hours), consistent with lung function of persons with mild episodic or mild persistent asthma is demonstrated. For the purpose of this protocol, an asthmatic individual will be defined as having a) positive methacholine challenge with a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) with less than or equal to 10 mg/ml; OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with the mild asthma
- Ability to withhold antihistamine medications for one week prior to baseline and allergen challenge visits.
- Subjects must be able and willing to give informed consent.
- Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers
Who cannot join
- Any chronic medical condition considered by the PI as a contraindication to the allergen challenge study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, bleeding disorder, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
- Use of inhaled or nasal steroids, cromolyn or leukotriene receptor antagonists (Montelukast or Zafirkulast) within the past month (except for use of cromolyn exclusively prior to exercise).
- Use of allergen immunotherapy.
- Use of daily theophylline within the past month.
Show all 20Show fewer
- Use of nasal medications that might alter the response to nasal allergen challenge including anti-inflammatory and anti-histamine agents within one week of challenge.
- Inability to withhold inhaled or oral bronchodilator medications for 12 hours prior to allergen challenge.
- Pregnancy or nursing a baby.
- Women of child-bearing age who are not using dependable contraception (such as birth control pills, IUD, estrogen patches) or who are not completely abstinent.
- 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.
- Exacerbation of asthma more than 2x/week which would be characteristic of a person with moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- 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).
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of challenge.
- Participating in an allergen inhalation study within 2 weeks of this challenge or use of any investigational agent within the last 30 days.
- Use of tricyclic antidepressants or beta-blockers.
- Use of MAO inhibitors or any medications known to interfere with the treatment of anaphylaxis.
- Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases.
- Subjects with acute inflammatory conditions in the nose or paranasal sinuses, such as sinusitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599-7310
About this study
The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of felis domesticus, or cat, extract in e-cigarette users, cigarette smokers, and non-smokers.
Read the detailed description
The recent increase in popularity of e-cigarettes for smoking cessation or in combination with conventional cigarettes has let to safety concerns regarding their potential role in respiratory disease. These tobacco alternatives devices were initially perceived as a "safer" alternative to cigarettes and were marketed without much known about their health effects. Increasing evidence that while they contain fewer toxins and carcinogens than conventional cigarettes, they do involve delivery of ultrafine particles to the lower airways and can contain heavy metals and other chemicals. Tobacco Smoke may augment allergic inflammation resulting from allergic rhinitis and/or asthma. Animal models of allergic asthma demonstrate aggravation of allergen -induced airway inflammation following inhalation of e-cig cartridge solution, with increased airway eosinophil infiltration, production of Th2 cytokines, and airway hyperresponsivness. In vitro studies in human tissues have demonstrated pro-inflammatory responses in a similar way as tobacco smoke, yet a head-to-head comparison of the effects of these two exposures has not been performed in humans.
Use of tobacco products remains a pervasive problem in our society and around the world, with significant impact on respiratory health and quality of life. With the emergence of new non-tobacco based nicotine products like e-cigarettes, it is important to understand the impact these substances have on respiratory health and disease. The aim o f this study is to study the impact of these products on allergic inflammation in cat allergic subjects who already routinely use e-cigarettes and to compare their response to those of cigarette smokers and non-smokers. A thorough understanding of the potential health impacts of tobacco alternative substances in seeded, especially given the rising popularity of such products with adolescents and young adults to whom these substances have particular appeals given the purported safety: and variety of flavors to chose from.
- Conditions
- Tobacco Smoking, Healthy Participants, E-cigarette Smokers
- Being tested
- Felis Domesticus
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felis DomesticusBiological
Also called Cat Allergen
Nasal Administration of Felis Domesticus
| Study group | Role | What they receive |
|---|---|---|
| Felis Domesticus treated Non-smoker | Active comparator | Not described Receives: Biological: Felis Domesticus |
| Felis Domesticus treated E-cigarette smoker | Active comparator | Not described Receives: Biological: Felis Domesticus |
| Felis Domesticus treated Cigarette smoker | Active comparator | Not described Receives: Biological: Felis Domesticus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eosinophils/mL in nasal lavage fluid (NLF)
NLF will be collected immediately prior to administration of the nasal allergen challenge. 4 hours after administration of a bolus provocative dose of allergen (determined at screening day visit nasal allergen challenge), NLF will be collected. Pre- and 4 hours post-challenge NLF will be analyzed for cellularity. Values will be compared across e-cigarette smokers, tobacco cigarette smokers, and non-smokers.
Measured: Pre- and 4 hours post- nasal allergen challenge
Secondary outcomes (2)
Nasal lavage fluid cytokines
NLF will be collected immediately prior to administration of the nasal allergen challenge, and 4 hours post-nasal allergen challenge. Cytokine levels will be quantified with commercially available ELISAs.
Measured: Pre- and 4 hours post- nasal allergen challenge
Nasal epithelial cell messenger ribonucleic acid (mRNA)
Nasal epithelial cell biopsies will be collected at baseline (within two months of nasal allergen challenge), and 4 hours post-nasal allergen challenge. Gene expression changes will be quantified using qRT-PCR.
Measured: Baseline (within two months of nasal allergen challenge) and 4 hours post- nasal allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start3 Apr 2017
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031145
- Sponsor's protocol ID
- 16-1686
- Acronym
- Kitty Nose
- Status last verified
- May 2021
- First submitted
- 21 Jan 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Impact of Smoking Status on Allergen-induced Nasal Airway Inflammation Using a Cat Hair (Felis Domesticus) Extract Nasal Allergen Challenge Model
- ClinicalTrials.gov ID
- NCT03031145
- Acronym / sponsor ID
- Kitty Nose / 16-1686
- Conditions
- Tobacco Smoking, Healthy Participants, E-cigarette Smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate allergen-induced nasal airway inflammation following nasal application of felis domesticus, or cat, extract in e-cigarette users, cigarette smokers, and non-smokers.
Detailed description
The recent increase in popularity of e-cigarettes for smoking cessation or in combination with conventional cigarettes has let to safety concerns regarding their potential role in respiratory disease. These tobacco alternatives devices were initially perceived as a "safer" alternative to cigarettes and were marketed without much known about their health effects. Increasing evidence that while they contain fewer toxins and carcinogens than conventional cigarettes, they do involve delivery of ultrafine particles to the lower airways and can contain heavy metals and other chemicals. Tobacco Smoke may augment allergic inflammation resulting from allergic rhinitis and/or asthma. Animal models of allergic asthma demonstrate aggravation of allergen -induced airway inflammation following inhalation of e-cig cartridge solution, with increased airway eosinophil infiltration, production of Th2 cytokines, and airway hyperresponsivness. In vitro studies in human tissues have demonstrated pro-inflammatory responses in a similar way as tobacco smoke, yet a head-to-head comparison of the effects of these two exposures has not been performed in humans.
Use of tobacco products remains a pervasive problem in our society and around the world, with significant impact on respiratory health and quality of life. With the emergence of new non-tobacco based nicotine products like e-cigarettes, it is important to understand the impact these substances have on respiratory health and disease. The aim o f this study is to study the impact of these products on allergic inflammation in cat allergic subjects who already routinely use e-cigarettes and to compare their response to those of cigarette smokers and non-smokers. A thorough understanding of the potential health impacts of tobacco alternative substances in seeded, especially given the rising popularity of such products with adolescents and young adults to whom these substances have particular appeals given the purported safety: and variety of flavors to chose from.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Felis Domesticus treated Non-smoker | Active comparator | Biological: Felis Domesticus |
| Felis Domesticus treated E-cigarette smoker | Active comparator | Biological: Felis Domesticus |
| Felis Domesticus treated Cigarette smoker | Active comparator | Biological: Felis Domesticus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females age 18-50 years
- Specific allergy to cat hair Felis domesticus confirmed by positive immediate skin test response
- Subjects may be enrolled with mild asthma if a Forced Expiratory Volume in 1 second (FEV1) of at least 80% of predicted and a Forced Expiratory Volume in 1 second to Forced Vital Capacity (FVC) ratio (FEV1/FVC ratio) of at least .75 (without use of bronchodilator medications for 12 hours), consistent with lung function of persons with mild episodic or mild persistent asthma is demonstrated. For the purpose of this protocol, an asthmatic individual will be defined as having a) positive methacholine challenge with a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) with less than or equal to 10 mg/ml; OR b) physician diagnosed asthma with symptoms and chronic daily therapy consistent with the mild asthma
- Ability to withhold antihistamine medications for one week prior to baseline and allergen challenge visits.
- Subjects must be able and willing to give informed consent.
Key exclusion criteria (20 listed)
- Any chronic medical condition considered by the PI as a contraindication to the allergen challenge study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, bleeding disorder, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation.
- Use of inhaled or nasal steroids, cromolyn or leukotriene receptor antagonists (Montelukast or Zafirkulast) within the past month (except for use of cromolyn exclusively prior to exercise).
- Use of allergen immunotherapy.
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 DomesticusAlso: Cat AllergenNasal Administration of Felis Domesticus | Biological | Felis Domesticus treated Cigarette smoker, Felis Domesticus treated E-cigarette smoker, Felis Domesticus treated Non-smoker |
Primary outcome
Change in eosinophils/mL in nasal lavage fluid (NLF)
Time frame: Pre- and 4 hours post- nasal allergen challenge
NLF will be collected immediately prior to administration of the nasal allergen challenge. 4 hours after administration of a bolus provocative dose of allergen (determined at screening day visit nasal allergen challenge), NLF will be collected. Pre- and 4 hours post-challenge NLF will be analyzed for cellularity. Values will be compared across e-cigarette smokers, tobacco cigarette smokers, and non-smokers.
2 secondary outcomes
Nasal lavage fluid cytokines
Time frame: Pre- and 4 hours post- nasal allergen challenge
Nasal epithelial cell messenger ribonucleic acid (mRNA)
Time frame: Baseline (within two months of nasal allergen challenge) and 4 hours post- nasal allergen challenge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Felis Domesticus in people with Tobacco Smoking and Healthy Participants, 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 20 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: withdrawn, as of the sponsor's last update on 7 May 2021. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in eosinophils/mL in nasal lavage fluid (NLF) (time frame: Pre- and 4 hours post- nasal allergen 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 7 May 2021.