Status:
COMPLETED
A Phase IIa Repeat Dose AXP1275 vs Placebo Cross-over Trial With Pulmonary Allergen Challenge in Adults With Asthma
Lead Sponsor:
Axikin Pharmaceuticals, Inc.
Conditions:
Atopic Asthma
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 subjec...
Eligibility Criteria
Inclusion
- Age 18 to 64 years (inclusive).
- Male or female.
- If male, is surgically sterile (vasectomy) or agrees to comply with required contraceptive measures.
- If female, not pregnant (or lactating), as evidenced by a negative serum pregnancy test, and is either surgically sterile (hysterectomy, bilateral ovariectomy, or bilateral tubal ligation), or if a female of childbearing potential, agrees to comply with required contraceptive measures.
- History of episodic wheeze and shortness of breath with a prebronchodilator FEV1 ≥70% of predicted at screening.
- Asthma symptoms treated (if necessary) only with intermittent short-acting ß-agonist therapy by inhalation.
- Demonstration of a positive wheal reaction on skin prick testing to at least 1 common aeroallergen at screening.
- Screening inhalational allergen challenge response demonstrating that the subject experiences both an early asthmatic response (EAR) and a late asthmatic response (LAR).
- Methacholine PC20 ≤16 mg/mL at screening.
- No history of smoking within 6 months of screening, and with a total pack year history of ≤10 pack years.
- 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
- All values for hematology, clinical chemistry, and urinalysis within the normal range, or if abnormal, are deemed not clinically significant by the investigator with documented agreement from the medical monitor.
- Is able to give written informed consent.
Exclusion
- Past or present disease which, as judged by the investigator, may affect the outcome of this study.
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the screening period.
- Symptomatic allergic rhinitis. Those subjects with a history of allergic rhinitis may participate if asymptomatic at screening (and continue to be so at baseline on Day 1 prior to dosing) and if, in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study.
- History of life-threatening asthma.
- Abnormal chest X-ray.
- Use of oral, injectable, or dermal steroids within 3 months and/or inhaled steroids within 1 month of screening.
- Use of cromoglycate, nedocromil, leukotriene receptor antagonists (zafirlukast, pranlukast, montelukast), and inhibitors of 5-lipoxygenase (zileuton) within 4 weeks of screening.
- Use of immunosuppressives, anticoagulants (warfarin or heparin), or any medications that may interact with pharmacodynamic (PD) effects of AXP1275 within 4 weeks of screening.
- Use of theophylline-containing agents (any type) and long-acting β2-agonists (salmeterol, formoterol) within 4 weeks of screening.
- Positive screen for drug(s) of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, or benzodiazepines) or cotinine.
- Positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) 1/2.
- Has participated in a clinical trial and has received an investigational product within 30 days prior to screening, or 5 elimination half lives of the investigational product, whichever is longer.
- Has had significant blood loss (\>500 mL) or donation of blood within 2 months prior to screening visit 1.
- History of being unable to tolerate or complete methacholine or allergen challenge tests.
- Subject is undergoing allergen desensitization therapy.
- History of immunotherapy in the 3 years prior to screening or concurrently undergoing immunotherapy treatment.
- Professional or ancillary personnel involved in the study.
- Is not, in the opinion of the investigator, suitable for entry into the study.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01890161
Start Date
August 1 2013
End Date
April 1 2014
Last Update
February 5 2016
Active Locations (3)
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1
Vancouver General Hospital, The Lung Centre
Vancouver, British Columbia, Canada, V5Z 1M9
2
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
3
IUCPQ, Institut de cardiologie et de pneumologie de l'Hôpital Laval
Québec, Quebec, Canada, G1V 4G5