Trial Outcomes & Findings for Imaging Study of the Lungs During an Allergic Asthma Attack (NCT NCT01547286)
NCT ID: NCT01547286
Last Updated: 2017-11-22
Results Overview
Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).
COMPLETED
NA
7 participants
3 hours after allergen administration
2017-11-22
Participant Flow
Subjects were recruited using an IRB approved advertisement from December 2012 - January 2013. Potential subjects completed two screening visits, during which the informed consent was obtained, clinical assessment, spirometry, methacholine challenge and allergic skin tests were performed. All screening visits took place at our pulmonary clinics.
This is a single group design study. Subjects were instructed to withhold their asthma and allergy medications before the screening and bronchial allergen challenge tests. The duration of the medication withholding depended on which medications they were using at that time.
Participant milestones
| Measure |
Allergic Asthmatic
This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
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|---|---|
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Overall Study
STARTED
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7
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
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2
|
Reasons for withdrawal
| Measure |
Allergic Asthmatic
This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
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|---|---|
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Overall Study
Did not meet all eligibility criteria
|
1
|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Imaging Study of the Lungs During an Allergic Asthma Attack
Baseline characteristics by cohort
| Measure |
Allergic Asthmatic
n=7 Participants
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is \< 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge. Nebulized methacholine inhalation: Standard
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age, Continuous
|
22.7 years
STANDARD_DEVIATION 5.08 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours after allergen administrationBlood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).
Outcome measures
| Measure |
Allergic Asthmatic
n=5 Participants
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is \< 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard
|
|---|---|
|
Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside
|
-17.8 percentage
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: 7 hours after allergen administrationBlood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).
Outcome measures
| Measure |
Allergic Asthmatic
n=5 Participants
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is \< 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard
|
|---|---|
|
Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside
|
-26.3 percentage
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 3 hours after allergen administrationCoefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.
Outcome measures
| Measure |
Allergic Asthmatic
n=5 Participants
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is \< 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard
|
|---|---|
|
Coefficient of Variation Squared of Perfusion
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0.11 unitless
Standard Deviation 0.03
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SECONDARY outcome
Timeframe: 7 hours after allergen administrationCoefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.
Outcome measures
| Measure |
Allergic Asthmatic
n=5 Participants
Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is \< 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard
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|---|---|
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Coefficient of Variation Squared of Perfusion
|
0.15 unitless
Standard Deviation 0.07
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Adverse Events
Allergic Asthmatic
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert Scott Harris, MD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place