Asthma Clinical Trial
Official title:
Is Adenosine Monophosphate Superior to Histamine for Bronchial Provocation Test in Evaluation of Asthma?
Adenosine monophosphate (AMP) may reflect airway inflammation and hyperresponsiveness, but
relationship between AMP and histamine (His, a conventional stimulus) bronchial provocation
test (BPT) in asthma is not fully elucidated.
The investigators aimed to compare both BPTs and determine their usefulness in reflecting
changes of asthmatic symptoms.
BPTs were performed in cross-over fashion, at 2-4day intervals. Cumulative doses eliciting
20% FEV1fall (PD20FEV1), diagnostic performance and adverse events were compared. Patients
with PD20FEV1 lower than geometric mean were defined as responders, otherwise poor
responders. Patients with uncontrolled and partly controlled asthma, who maintained their
original inhaled corticosteroids therapy, underwent reassessment of airway responsiveness
and asthmatic symptoms 3 and 6 months after.
Airway hyperresponsiveness, the pivotal feature of asthma, can be assessed by bronchial
provocation tests (BPTs), which may elicit bronchoconstriction via inhalation of stimuli.
Histamine has been a direct stimulus for inducing bronchoconstriction via vasodilation,
eosinophil chemotaxis and tissue edema. Clinically, histamine BPT (His-BPT) has gained
extensive application for decades owing to the assay sensitivity and feasibility, but could
not ideally predict anti-inflammatory treatment outcomes in practice. Additionally, mild
adverse events (flushing and hoarseness) and insufficient capacity of identifying
exercise-induced asthma have hampered further clinical applications.
Adenosine monophosphate (AMP) is an inflammatory mediator that serves as an indirect
bronchial stimulus for detecting airway hyperresponsiveness in asthma. Compared with
histamine, AMP may be pathophysiologically more relevant to airway inflammation and
hyperresponsiveness and has been linked to presence and magnitude of atopy. However,
differences of response to AMP-BPT and His-BPT in different asthma control levels and their
associations with asthmatic symptom scores have not been fully elucidated.
We hypothesized that asthmatic patients, regardless of control levels, responded
differentially to AMP-BPT and His-BPT, and that greater reduction in airway responsiveness
to AMP (esp. responders of AMP-BPT) was associated with significant symptom alleviation.
Henceforth, we sought to: 1) compare diagnostic performance and safety of AMP-BPT and
His-BPT in different asthma control levels; 2) determine the association between airway
responsiveness and asthmatic symptom scores.
Currently, His-BPT is recommended by the Chinese guideline and shares considerable
similarity with methacholine (another conventional stimulus) BPT, we therefore did not
perform the latter in this study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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