This trial is active, not recruiting.

Condition copd
Treatments aqx-1125, placebo
Phase phase 2
Sponsor Aquinox Pharmaceuticals, Inc.
Start date October 2013
End date June 2015
Trial size 400 participants
Trial identifier NCT01954628, AQX-1125-202


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
1 x AQX-1125 capsule daily
Synthetic SHIP1 activator
(Placebo Comparator)
1 x Placebo capsule daily
Placebo control

Primary Outcomes

Change from baseline in EXACT score
time frame: 12 weeks

Secondary Outcomes

Change from baseline in CAT score
time frame: 12 weeks
Change from baseline in FEV1
time frame: 12 weeks
Safety determined by adverse events [AEs], physical examinations, laboratory tests, electrocardiogram [ECG] and ophthalmic examinations
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title The FLAGSHIP Study: A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Aquinox Pharmaceuticals, Inc..