This is the first study in human patients with asthma that the sponsor is conducting in order to evaluate if there are signals that the investigational medication, AXP1275, may be a safe and effective treatment for asthma. The results of this study may help the sponsor to design additional studies.
This 2-way, randomized, double-blind crossover study in subjects with mild to moderate atopic asthma is designed to compare the responses to allergen and methacholine challenges within the same subject after approximately 2 weeks of treatment with AXP1275 50 mg or placebo. A total of 20 subjects with asthma with a dual (early and late) asthmatic response to an inhaled aeroallergen will be randomized to 1 of 2 treatment sequences (placebo then AXP1275 or AXP1275 then placebo) in a double-blind fashion to receive either oral AXP1275 or matching placebo, once-daily, for 14 days. The washout period between the 2 treatment periods will be 14 to 21 days. A post-treatment follow-up visit will occur 14 ± 3 days after completion of the second treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
AXP1275 50 mg (2 × 25-mg capsules)
AXP1275 matching placebo (2 capsules)
Vancouver General Hospital, The Lung Centre
Vancouver, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
IUCPQ, Institut de cardiologie et de pneumologie de l'Hôpital Laval
Québec, Quebec, Canada
Late Asthmatic Response
Area under the forced expiratory volume in 1 second (FEV1) curve from 3 to 7 hours after allergen challenge (AUC3-7h) on day 13 of both 14-day treatment periods.
Time frame: From 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods
Early Asthmatic Response
Maximum percentage fall in FEV1 and AUC of FEV1 between 0 to 2 hours (AUC0-2h) after allergen challenge on day 13 of both 14-day treatment periods.
Time frame: Between 0 to 2 hours after allergen challenge on day 13 of both 14-day treatment periods
Late Asthmatic Response-Secondary
Maximum percentage fall in FEV1 between 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods.
Time frame: Between 3 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods
Total Asthmatic Response
Minimum FEV1 and AUC of FEV1 between 0-7 hours (AUC0 7h) after allergen challenge on day 13 of both 14-day treatment periods.
Time frame: Between 0 to 7 hours after allergen challenge on day 13 of both 14-day treatment periods
FEV1 comparison
For FEV1 values at each time point on day 12, 13, and 14, the difference between the two treatments will be calculated.
Time frame: At day 12, 13, and 14 of both 14-day treatment periods
Sputum eosinophil count
Induced sputum eosinophil count per mL of sputum on days 12, 13, and 14 of both 14-day treatment periods.
Time frame: On days 12, 13, and 14 of both 14-day treatment periods
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Sputum cell count (other)
Induced sputum cell count per mL of sputum for cells other than eosinophils (including basophils) on days 1, 12, 13, and 14 of both 14-day treatment periods.
Time frame: On days 1, 12, 13, and 14 of both 14-day treatment periods
CCL13 and CCL17 concentrations
Comparison of the two treatments for changes in sputum concentrations of CCL13 and CCL17.
Time frame: On days 12, 13, and 14 of both 14-day treatment periods
Provocative concentration of methacholine
Shift in the provocative concentration of methacholine resulting in a 20% reduction in FEV1 (PC20) between days 1 and 12 and between days 12 and 14 of both 14-day treatment periods.
Time frame: Between days 1 and 12 and between days 12 and 14 of both 14-day treatment periods
Maximum exhaled nitric oxide (eNO) and AUC of eNO
Maximum eNO and AUC of eNO on days 13 and 14 (AUC0-24h) of both 14-day treatment periods.
Time frame: On days 13 and 14 of both 14-day treatment periods
eNO comparison
For eNO values at each time point on day 13, and 14 of both 14-day treatment periods, the difference between the two treatments will be calculated.
Time frame: On days 13 and 14 of both 14-day treatment periods