Efficacy and Safety of AQX-1125 in Unstable COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: COPD

In brief

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.

Key facts

Study ID

NCT01954628

Run by

Aquinox Pharmaceuticals (Canada) Inc.

People needed

400

Starts

2013-10-01

Expected to finish

2015-12-01

Last updated by the study team

2017-06-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged ≥40 years at screening
• History of COPD for at least 18 months prior to screening, characterised by excessive sputum production
• 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
• At least 2 documented exacerbations during the last 18 months prior to screening.
• 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
• 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.
• Former smoker or current smoker, both with a smoking history of at least 10 pack years

You may not qualify if…

• Diagnosis of other relevant lung disease (e.g. asthma, cystic fibrosis [CF] or significant non-CF bronchiectasis)
• Known alpha-1-antitrypsin deficiency
• Treatment with roflumilast or theophylline within 1 month prior to screening
• 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
• Hospitalisation for more than 7 days for current acute exacerbation, or the requirement for intubation during hospitalisation
• For outpatients, prior medical history indicating that previous exacerbations required >3 weeks to stabilise

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States
• Department of Respiratory & Sleep Medicine, Westmead Hospital — Wentworthville, New South Wales, Australia
• Department of Respiratory Medicine, Odense University Hospital — Odense, Denmark
• Biomedicum Helsinki — Helsinki, Finland
• Csongrád Megyei Melkasi Betegségek Szakkórháza — Deszk, Hungary
• P3 Research — Wellington, New Zealand
• Medical University of Lodz — Lodz, Poland
• Lung and Allergy Clinic, Skåne University Hospital — Lund, Sweden

Full record on ClinicalTrials.gov

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