Efficacy and Safety of AQX-1125 in Unstable COPD

COPD Clinical Trial

— FLAGSHIP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01954628
• Other study ID #: AQX-1125-202
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 21, 2013
• Last updated: February 4, 2015
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2014
• Source: Aquinox Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFinland: Finnish Medicines AgencyDenmark: Danish Health and Medicines AuthorityHungary: National Institute of PharmacyPoland: The Central Register of Clinical TrialsAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AQX-1125
Synthetic SHIP1 activator
• Placebo
Placebo control

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aquinox Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Finland,  Hungary,  New Zealand,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AQX-1125 concentrations in plasma (trough values)	The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma	12 weeks	No
Primary	Change from baseline in EXACT score	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.	12 weeks	No
Secondary	Change from baseline in CAT score	The secondary objective is 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	12 weeks	No
Secondary	Change from baseline in FEV1	The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on forced expiratory volume in 1 second [FEV1]	12 weeks	No
Secondary	Safety determined by adverse events [AEs], physical examinations, laboratory tests, electrocardiogram [ECG] and ophthalmic examinations	The secondary objectives are to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on 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	12 weeks	Yes

External Links

•   GOLD COPD Guidelines