Healthy Participants Clinical Trial
— Kitty NoseOfficial 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
Verified date | May 2021 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 4, 2017 |
Est. primary completion date | December 4, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Males and females age 18-50 years 2. Specific allergy to cat hair Felis domesticus confirmed by positive immediate skin test response 3. 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 4. Ability to withhold antihistamine medications for one week prior to baseline and allergen challenge visits. 5. Subjects must be able and willing to give informed consent. 6. Subjects will be classified as tobacco smokers, e-cigarette users, or non-smokers Exclusion Criteria: 1. 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. 2. Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months. 3. Use of systemic steroid therapy within the preceding 12 months for treatment of an asthma exacerbation. 4. 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). 5. Use of allergen immunotherapy. 6. Use of daily theophylline within the past month. 7. 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. 8. Inability to withhold inhaled or oral bronchodilator medications for 12 hours prior to allergen challenge. 9. Pregnancy or nursing a baby. 10. 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. 11. 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. 12. 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. 13. 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). 14. Viral upper respiratory tract infection within 4 weeks of challenge. 15. Any acute infection requiring antibiotics within 4 weeks of challenge. 16. Participating in an allergen inhalation study within 2 weeks of this challenge or use of any investigational agent within the last 30 days. 17. Use of tricyclic antidepressants or beta-blockers. 18. Use of MAO inhibitors or any medications known to interfere with the treatment of anaphylaxis. 19. Subjects with a history of immunologic disease or undergoing immune suppression for cancer or other diseases. 20. Subjects with acute inflammatory conditions in the nose or paranasal sinuses, such as sinusitis. |
Country | Name | City | State |
---|---|---|---|
United States | UNC Center for Environmental Medicine, Asthma and Lung Biology | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Pre- and 4 hours post- nasal allergen challenge | |
Secondary | 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. | Pre- and 4 hours post- nasal allergen challenge | |
Secondary | 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. | Baseline (within two months of nasal allergen challenge) and 4 hours post- nasal allergen challenge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05445440 -
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
|
Phase 1 | |
Completed |
NCT03712540 -
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
|
Phase 1 | |
Completed |
NCT03649165 -
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT05956002 -
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
|
Phase 1 | |
Completed |
NCT05539976 -
A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
|
||
Withdrawn |
NCT04558216 -
Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants
|
Phase 1 | |
Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
Completed |
NCT06097390 -
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
|
Phase 1 | |
Completed |
NCT05546151 -
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
|
Phase 1 | |
Completed |
NCT05056246 -
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
|
Phase 1 | |
Completed |
NCT04390776 -
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
|
Phase 1 | |
Completed |
NCT05074459 -
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
|
Phase 1 | |
Enrolling by invitation |
NCT06089109 -
Creating VIP Corps to Reduce Maternal Deaths
|
N/A | |
Completed |
NCT05996250 -
Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects
|
N/A | |
Completed |
NCT03278080 -
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1
|
N/A | |
Completed |
NCT05064800 -
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
|
Phase 1 | |
Completed |
NCT04471298 -
A Study of Qishenyiqi Dripping Pills in Healthy Participants
|
Phase 1 | |
Completed |
NCT04914936 -
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
|
Phase 1 | |
Completed |
NCT01681186 -
A Study of LY2940680 in Healthy Participants
|
Phase 1 | |
Completed |
NCT02563262 -
Human Neutral Body Posture in Weightlessness
|
N/A |