Asthma
Conditions
Keywords
asthma, bronchoprovocation challenge test, mannitol, methacholine
Brief summary
This is an ancillary study conducted as part of the BASALT trial \[NCT00495157\]. The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges
Interventions
DRUGmannitol
indirect mannitol challenge
Sponsors
Syntara
National Heart, Lung, and Blood Institute (NHLBI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* all subjects randomized to the BASALT protocol
Exclusion criteria
* positive urine pregnancy test * requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | At 6 weeks, 20 weeks, and 32 weeks | Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial | Baseline | To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements and methacholine bronchoprovocation performance as collected in the BASALT trial. |
Countries
United States
Outcome results
None listed