Efficacy and Safety of AQX-1125 in Unstable COPD

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aquinox Pharmaceuticals (Canada) Inc.

Criteria

Inclusion Criteria:

1. Male or female aged ≥40 years at screening

2. History of COPD for at least 18 months prior to screening, characterised by excessive sputum production

3. 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

4. At least 2 documented exacerbations during the last 18 months prior to screening.

5. 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

6. Ability to perform pulmonary function testing and with documented fixed airway obstruction determined by an FEV1 /FVC [forced vital capacity] ratio (post-bronchodilator) of <0.70 and a predicted FEV1 value of 30%-80% of normal within the 6 months prior to Visit 1.

7. Former smoker or current smoker, both with a smoking history of at least 10 pack years

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. 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

5. Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation

6. For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise