Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448851
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2007-03-15
Brief Title:
Study of Dust Mite Inhalation in Humans
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Phase 1 Study of Dermatophagoides Farinae Inhalation in Humans
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to learn more about the effect of inhaled dust mite allergen extract on airway responses in allergic individuals with mild asthma Information learned from this study will be used to identify a safe dose range of D Farinae extract for use in inhalation challenge studies This study will also help determine how inhalation of the allergen affects mucociliary clearance MCC which is a measure of how quickly mucus clears from the airway
Detailed Description:
This will be a non-blinded study of the effect of inhaled house dust mite D Farinae allergen extract on airway responses with the principal endpoint being a decrease in FEV1 of 15 within 10 minutes after inhalation of one of a sequence of doses of allergen compared with measurements obtained immediately prior to challenge These doses will be delivered as 5 inhalations of allergen at concentrations of 025 050 10 20 40 80 16 32 64 125 250 500 1000 and 2000 AUmL Allergen challenge often induces an immediate and late phase decrease in lung function The immediate phase that occurs within 10 minutes often self resolves and is associated with release of histamine from airway mast cells while the late phase response often occurs 2 to 8 hours later and is associated with increased airway inflammation
During the subjects baseline visit occurring at least 2 days prior to allergen challenge we will measure mucociliary clearance MCC of inhaled radiolabeled particles by gamma scintigraphy The subject will return 24 hours later for a follow-up scan and a sputum sample will also be collected At 4 hours post allergen challenge we will again measure MCC as an exploratory endpoint It is expected that mucociliary clearance will be depressed as part of a late phase reaction to allergen challenge Twenty-four hours after allergen challenge induced sputum will be obtained and compared with the sputum sample obtained at the baseline visit Exploratory endpoints of interest from examination of induced sputum will also be collected after inhaled allergen challenge
Observation Schedule details regarding study procedures follow below
Baseline visit
1 Consent will be obtained
2 Review of subjects medical history and current medications
3 Vital sign measurements temperature pulse respiratory rate blood pressure oxygen saturation and symptom scoring
4 Urine pregnancy test for women of child bearing potential
5 Spirometry
6 Physical exam of the ears nose throat and chest
7 Xenon equilibrium gas scan
8 Mucociliary clearance procedure MCC
24 hours post baseline visit
1 Review any change in medical status over prior 24 hours
2 Vital signs oxygen saturation and symptom score
3 Follow up MCC scan
4 Sputum induction
Post Challenge ObservationsReporting Subjects will be contacted for phone call follow-up 24 hours after sputum induction see accompanying phone script
24-48 hours prior to challenge visit at least 2 days after the baseline visit
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Physical exam of the ears nose throat and chest
Allergen challenge day
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Urine pregnancy test
4 Spirometry
5 If above measures are acceptable allergen challenge will be performed as described
6 Post-challenge monitoring at intervals indicated on study worksheets
7 Four hours post challenge subject will have MCC evaluated
8 Overnight stay in the UNC General Clinical Research Center GCRC Subjects will be instructed to perform either spirometry with a personal spirometer or peak flow assessments on an every other hourly basis until at least 9 pm and up to 11 pm if the subject is awake
24 hours post challenge
1 Subject is discharged from GCRC and accompanied by a study staff member proceeds directly to CEMALB
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Follow-up MCC scan
5 Sputum induction
Post Challenge ObservationsReporting
1 Subjects will be contacted for phone call follow-up 24 hours after post-challenge sputum induction see accompanying phone script
2 Each volunteer will be given a symptom scoring sheet for each day up to 96 hours 4 days after challenge see accompanying symptom scoring sheet
Study discontinuation visit within 10 days of the final challenge dose
1 Vital signs oxygen saturation and symptom score
2 Spirometry
3 If any findings are abnormal medical evaluation as directed by the study physician will be undertaken
During the subjects baseline visit occurring at least 2 days prior to allergen challenge we will measure mucociliary clearance MCC of inhaled radiolabeled particles by gamma scintigraphy The subject will return 24 hours later for a follow-up scan and a sputum sample will also be collected At 4 hours post allergen challenge we will again measure MCC as an exploratory endpoint It is expected that mucociliary clearance will be depressed as part of a late phase reaction to allergen challenge Twenty-four hours after allergen challenge induced sputum will be obtained and compared with the sputum sample obtained at the baseline visit Exploratory endpoints of interest from examination of induced sputum will also be collected after inhaled allergen challenge
Observation Schedule details regarding study procedures follow below
Baseline visit
1 Consent will be obtained
2 Review of subjects medical history and current medications
3 Vital sign measurements temperature pulse respiratory rate blood pressure oxygen saturation and symptom scoring
4 Urine pregnancy test for women of child bearing potential
5 Spirometry
6 Physical exam of the ears nose throat and chest
7 Xenon equilibrium gas scan
8 Mucociliary clearance procedure MCC
24 hours post baseline visit
1 Review any change in medical status over prior 24 hours
2 Vital signs oxygen saturation and symptom score
3 Follow up MCC scan
4 Sputum induction
Post Challenge ObservationsReporting Subjects will be contacted for phone call follow-up 24 hours after sputum induction see accompanying phone script
24-48 hours prior to challenge visit at least 2 days after the baseline visit
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Physical exam of the ears nose throat and chest
Allergen challenge day
1 Review any change in medical status since last visit
2 Vital signs oxygen saturation and symptom score
3 Urine pregnancy test
4 Spirometry
5 If above measures are acceptable allergen challenge will be performed as described
6 Post-challenge monitoring at intervals indicated on study worksheets
7 Four hours post challenge subject will have MCC evaluated
8 Overnight stay in the UNC General Clinical Research Center GCRC Subjects will be instructed to perform either spirometry with a personal spirometer or peak flow assessments on an every other hourly basis until at least 9 pm and up to 11 pm if the subject is awake
24 hours post challenge
1 Subject is discharged from GCRC and accompanied by a study staff member proceeds directly to CEMALB
2 Vital signs oxygen saturation and symptom score
3 Spirometry
4 Follow-up MCC scan
5 Sputum induction
Post Challenge ObservationsReporting
1 Subjects will be contacted for phone call follow-up 24 hours after post-challenge sputum induction see accompanying phone script
2 Each volunteer will be given a symptom scoring sheet for each day up to 96 hours 4 days after challenge see accompanying symptom scoring sheet
Study discontinuation visit within 10 days of the final challenge dose
1 Vital signs oxygen saturation and symptom score
2 Spirometry
3 If any findings are abnormal medical evaluation as directed by the study physician will be undertaken
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHLBI-RO1 HL080337 | OTHER_GRANT | National Heart Lung and Blood Institute NHLBI | None |