Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Product Name: AQX-1125
Product Code: AQX-1125
Pharmaceutical Form: Capsule
INN or Proposed INN: AQX-1125
CAS Number: 782487-29-0
Current Sponsor code: AQX-1125
Concentration unit: mg milligram(s)
Conc
Sponsors
Aquinox Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent and be willing and able to comply with all aspects of the study requirements 2. Male or female aged =40 years at screening 3. History of COPD for at least 18 months prior to screening, characterised by excessive sputum production 4. Chronic productive cough for at least 3 months in each of the 2 years prior to screening (if other causes of productive cough have been excluded) and/or an exacerbation of COPD with predominantly bronchitic symptoms at enrolment 5. At least 2 documented exacerbations during the last 18 months prior to screening. If the subject has experienced exacerbations during the last 18 months that were self-treated at home and subsequently documented by a physician, this can be documented at Visit 1 6. Presentation of a diagnosed acute exacerbation of COPD, or have recently (within 3 days) been discharged from hospital due to an acute exacerbation of COPD 7. Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /forced vital capacity (FVC) ratio (post-bronchodilator) of =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis) 2. Known alpha-1-antitrypsin deficiency 3. Treatment with roflumilast or theophylline within 1 month prior to screening 4. History of alcohol or drug abuse in the past 3 years prior to screening 5. Participation in another clinical research study within 90 days prior to screening 6. Lobar pneumonia, with current positive chest X-ray (CXR) or within the 3 months prior to screening including the presence of any new radiological infiltrate on CXR within the previous two weeks 7. Have any other conditions, disease or circumstances which, in the opinion of the Investigator, could compromise safety of the subject or confound the interpretation of the study results. This will include a relevant documented medical history of clinically significant irregularities in kidney function, liver function or blood counts; or malignant or premalignant irregularities of the urinary bladder. 8. Serious and/or life-threatening co-existing conditions that would merit acute hospitalisation, aside from the acute exacerbation event These include, but are not limited to, acute myocardial infarction, acute renal failure, acute pancreatitis, thromboembolic disease, and diabetic ketoacidosis 9. Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation 10. For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise 11. Known intolerance to micro-crystalline cellulose (Avicel® PH-102)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Twelve weeks;Secondary Objective: To evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on: • The COPD Assessment Tool (CAT) score • Pulmonary function (including but not limited to forced expiratory volume in 1 second [FEV1]) • The frequency and severity of adverse events (AEs) and changes in, physical examination, vital signs, ophthalmic examination, laboratory tests, weight, electrocardiogram (ECG), and concomitant medications • The pharmacokinetics (PK) of AQX-1125 in plasma;Main Objective: The primary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on recurrent exacerbations as measured by EXACT (EXAcerbation of Chronic pulmonary disease Tool) in subjects with COPD following a recent exacerbation. ;Primary end point(s): The primary endpoint of this study is the difference in the “area above the curve” (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and subjects treated with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The difference in number of COPD exacerbations and time to first COPD exacerbation between subjects treated with AQX-1125 or placebo • The difference in change from baseline in CAT score between subjects treated with AQX-1125 or placebo • The difference in change from baseline in pulmonary function (FEV1, expressed in litres and as percent predicted normal) between subjects treated with AQX 1125 and subjects treated with placebo • The difference in number and frequency of AEs, physical examination, ECG, ophthalmology examination, and concomitant medications and changes from baseline for clinical laboratory assessments and vital signs between subjects treated with AQX 1125 and subjects treated with placebo • Trough AQX-1125 concentrations in plasma;Timepoint(s) of evaluation of this end point: Twelve weeks | — |
Countries
Australia, Denmark, Finland, Hungary, New Zealand, Poland, Sweden, United States
Contacts
Public ContactClinical Operations
TFS Trial Form Support AB
Outcome results
None listed