Trial Outcomes & Findings for Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers. (NCT NCT03023397)
NCT ID: NCT03023397
Last Updated: 2021-06-04
Results Overview
NLF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge. The protocol was amended to replace this outcome using Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF).
TERMINATED
PHASE1
12 participants
Baseline, 4 hours post-allergen challenge
2021-06-04
Participant Flow
Participants were recruited from individuals who completed the general screening process at the Center for Environmental Medicine, Asthma and Lung Biology.
Participant milestones
| Measure |
Non-smokers
Non-smoking adults with a history of dust mite allergy and allergic rhinitis
|
Cigarette Smokers
Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
|
E-cig Users
E-cig using adults with a history of dust mite allergy and allergic rhinitis
|
|---|---|---|---|
|
Run-In
STARTED
|
8
|
3
|
1
|
|
Run-In
COMPLETED
|
6
|
3
|
1
|
|
Run-In
NOT COMPLETED
|
2
|
0
|
0
|
|
Main Study
STARTED
|
6
|
3
|
1
|
|
Main Study
COMPLETED
|
6
|
3
|
1
|
|
Main Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Non-smokers
Non-smoking adults with a history of dust mite allergy and allergic rhinitis
|
Cigarette Smokers
Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
|
E-cig Users
E-cig using adults with a history of dust mite allergy and allergic rhinitis
|
|---|---|---|---|
|
Run-In
Failed screening allergen challenge
|
1
|
0
|
0
|
|
Run-In
Loss of funding after informed consent but before screening allergen challenge
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of the Effect of a Nasal Allergen Challenge With Dermatophagoides Farinae Extract on Nasal Airway Inflammation in Allergic Individuals, Comparing E-cigarette Users to Cigarette Smokers and Non-smokers.
Baseline characteristics by cohort
| Measure |
Non-smokers
n=8 Participants
Non-smoking adults with a history of dust mite allergy and allergic rhinitis
|
Cigarette Smokers
n=3 Participants
Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
|
E-cig Users
n=1 Participants
E-cig using adults with a history of dust mite allergy and allergic rhinitis
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
29.6 Years
n=5 Participants
|
34.6 Years
n=7 Participants
|
21.4 Years
n=5 Participants
|
29 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 hours post-allergen challengePopulation: NLF samples obtained from six non-smokers, 3 smokers and 1 e-cig user were contaminated with blood and therefore were not suitable samples for analysis of nasal inflammatory cells. The protocol was changed to include eosinophilic cationic protein (ECP) in nasal epithelial lining fluid (NELF) as the primary outcome measure.
NLF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge. The protocol was amended to replace this outcome using Eosinophilic Cationic Protein (ECP) in Nasal Epithelial Lining Fluid (NELF).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: baseline, 4 hours post-allergen challengePopulation: Six non-smoking participants, 3 smoking participants and 1 e-cig using participant had paired pre and 4 hours post-challenge samples for analysis.
NELF will be collected immediately prior to administration of the nasal allergen challenge and 4 hours after completion of nasal allergen challenge.
Outcome measures
| Measure |
Non-smokers
n=6 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
|
Cigarette Smokers
n=3 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
E-cig Users
n=1 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
|---|---|---|---|
|
Mean Change in Eosinophilic Cationic Protein (ECP) Levels in Nasal Epithelial Lining Fluid (NELF)
|
31374 micrograms/L
Standard Deviation 37261
|
-50847 micrograms/L
Standard Deviation 45535
|
-17851 micrograms/L
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Pre- and 4 hours-post nasal allergen challengePopulation: Six non-smoking participants, 3 smoking participants and 1 e-cig using participant had paired pre and 4 hours post-challenge samples for analysis.
NELF will be collected immediately prior to administration of the nasal allergen challenge, and 4 hours post- nasal allergen challenge.
Outcome measures
| Measure |
Non-smokers
n=6 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
|
Cigarette Smokers
n=3 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
E-cig Users
n=1 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
|---|---|---|---|
|
Mean Change in Interleukin-31 (IL-31) Concentrations in NELF
|
0.76 picograms/mL
Standard Deviation 1.01
|
0.06 picograms/mL
Standard Deviation 0.28
|
4.76 picograms/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline, 4 hours post-allergen challengePopulation: Six non-smoking participants, 3 smoking participants and 1 e-cig using participant had paired pre and 4 hours post-challenge samples for analysis.
NELF will be collected immediately prior to administration of the nasal allergen challenge, and 4 hours post- nasal allergen challenge.
Outcome measures
| Measure |
Non-smokers
n=6 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
|
Cigarette Smokers
n=3 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
E-cig Users
n=1 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
|---|---|---|---|
|
Mean Change in Interleukin-5 (IL-5) Concentrations in NELF
|
75.82 picograms/mL
Standard Deviation 53.02
|
3.42 picograms/mL
Standard Deviation 4.58
|
240.9 picograms/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline, 4 hours post-allergen challengePopulation: Six non-smoking participants, 3 smoking participants and 1 e-cig using participant had paired pre and 4 hours post-challenge samples for analysis.
NELF will be collected immediately prior to administration of the nasal allergen challenge, and 4 hours post- nasal allergen challenge.
Outcome measures
| Measure |
Non-smokers
n=6 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
|
Cigarette Smokers
n=3 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
E-cig Users
n=1 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
|---|---|---|---|
|
Mean Change in Macrophage Inflammatory Protein 1 Alpha (MIP-1a) Concentration in NELF
|
72.52 picograms/mL
Standard Deviation 42.9
|
10.04 picograms/mL
Standard Deviation 8.03
|
91.43 picograms/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline, 4 hours post-allergen challengePopulation: Six non-smoking participants, 3 smoking participants and 1 e-cig using participant had paired pre and 4 hours post-challenge samples for analysis.
NELF will be collected immediately prior to administration of the nasal allergen challenge, and 4 hours post- nasal allergen challenge.
Outcome measures
| Measure |
Non-smokers
n=6 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a total nasal symptom score (TNSS) of 8 or more AND a reduction in peak nasal inspiratory flow (PNIF) of 20% or more (or until the highest allergen dose is administered).
|
Cigarette Smokers
n=3 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
E-cig Users
n=1 Participants
Intranasal administration of Dermatophagoides farinae allergen is performed until the participant reaches a TNSS of 8 or more AND a reduction in PNIF of 20% or more (or until the highest allergen dose is administered).
|
|---|---|---|---|
|
Mean Change in Macrophage Inflammatory Protein 1 Beta (MIP-1b) in NELF
|
370.8 picograms/mL
Standard Deviation 511.6
|
18.97 picograms/mL
Standard Deviation 12.01
|
32.98 picograms/mL
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 4 hours post- nasal allergen challengePopulation: No samples were analyzed due to lack of funding and early termination of the study
Nasal epithelial cell biopsies will be collected at baseline and 4 hours post- nasal allergen challenge. Gene expression changes will be quantified using quantitative real-time polymerase chain reaction (qRT-PCR).
Outcome measures
Outcome data not reported
Adverse Events
Non-smoker
Cigarette Smoker
E-cig User
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-smoker
n=8 participants at risk
Non-smoking adults with a history of dust mite allergy and allergic rhinitis
|
Cigarette Smoker
n=3 participants at risk
Cigarette smoking adults with a history of dust mite allergy and allergic rhinitis
|
E-cig User
n=1 participants at risk
E-cig using adults with a history of dust mite allergy and allergic rhinitis
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Epistaxis
|
37.5%
3/8 • Number of events 3 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/3 • From the time of informed consent to the final study visit (up to 6 months).
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
|
Injury, poisoning and procedural complications
Headache
|
0.00%
0/8 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/3 • From the time of informed consent to the final study visit (up to 6 months).
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
|
Injury, poisoning and procedural complications
Rhinitis
|
12.5%
1/8 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/3 • From the time of informed consent to the final study visit (up to 6 months).
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/3 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/1 • From the time of informed consent to the final study visit (up to 6 months).
|
|
Injury, poisoning and procedural complications
Sneeze
|
12.5%
1/8 • Number of events 1 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/3 • From the time of informed consent to the final study visit (up to 6 months).
|
0.00%
0/1 • From the time of informed consent to the final study visit (up to 6 months).
|
Additional Information
Allison Burbank, MD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place