Mild to moderate asthma
Conditions
Interventions
Product Name: AQX-1125
Product Code: AQX-1125
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: -
CAS Number: -
Current Sponsor code: AQX 1125
Other descriptive name: AQX-1125 acetate
Concentrat
Sponsors
AQUINOX PHARMACEUTICALS INC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Documented history of bronchial asthma, at least 6 months prior to the Screening Visit 1 and treated only with intermittent short-acting ß2 agonist therapy, by inhalation. 2.Pre-bronchodilator FEV1=70% of predicted at Screening Visit 1. 3.Demonstration of a positive wheal reaction on skin prick testing at screening, or within 12 months of screening. 4.Screening IAC demonstrating that the subject experiences both an EAR and an LAR 5.Methacholine PC20 (The provocation concentration of methacholine causing a 20% fall in FEV1) =16 mg/mL at Screening Visit 2. 6.No history of smoking within 6 months of Screening Visit 1, and with a total pack year history of = 10 pack years. 7.Be able to give written signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 22 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Past or present disease which, as judged by the Investigator, may affect the outcome of this study. 2.Respiratory tract infection or exacerbation of asthma within 4 weeks prior to the first dose of study drug. 3.Symptomatic allergic rhinitis. 4.History of life-threatening asthma. 5.Administration of systemic glucocorticosteroid therapy steroids within 6 weeks or topical or inhaled steroids within 1 month of Screening Visit 1. 6.Positive drug or alcohol result at Screening Visit 1 or on Day 1 of either treatment period. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. 7.Subject has recently participated in a clinical trial and have received an investigational product 8.Subject is pregnant, planning to conceive or lactating. 9.History of being unable to tolerate or complete methacholine or allergen challenge tests. 10.Subjects, who, on more than 2 occasions, after 2 concurrent administrations of saline during the allergen challenge at screening, had a fall in FEV1 of greater than 10%. 11.Subject is undergoing allergen desensitisation therapy. History of immunotherapy in the 3 years prior to Screening Visit 1 or concurrently undergoing immunotherapy treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of treatment with once daily AQX-1125 on the LAR to IAC in subjects with mild to moderate atopic asthma.;Primary end point(s): The primary endpoint is the LAR which is defined as the baseline-corrected area under the FEV1 curve from 4 to 10 hours after allergen challenge (AUC4-10h) on Day 6 of each treatment period.;Secondary Objective: To compare the differences in leukocytes, eosinophils and other inflammatory markers after 7 days of AQX-1125 treatment versus placebo in subjects with mild to moderate atopic asthma. To evaluate the effect of once daily AQX-1125 treatment on the EAR to IAC and total asthmatic response to IAC in subjects with mild to moderate atopic asthma. To evaluate the effect of once daily AQX-1125 treatment on lung function measured by FEV1 post IAC. To compare differences in leukocytes and inflammatory markers in sputum after 7 days of AQX-1125 treatment versus placebo in subjects with mild to moderate atopic asthma. To evaluate the effect of once daily AQX-1125 treatment on bronchial hyper-reactivity as measured by methacholine challenge on Day 7 and on exhaled nitric oxide on Days 6 and 7 in subjects with mild to moderate atopic asthma. To evaluate the pharmacokinetics, safety and tolerability of AQX-1125 in subjects with mild to moderate atopic asthma. | — |
Countries
United Kingdom
Contacts
Public ContactDr Brian Leaker
Heart Lung Centre
Outcome results
None listed