Efficacy and Safety of AQX-1125 in Unstable COPD

NCT01954628 | Completed Phase 2 Results

• 1 other identifier: AQX-1125-202
• Study Type: interventional
• Target: 400
• Locations: 8 countries
• Sites: 8

Brief 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.

Conditions

COPD

Keywords

Exacerbation of COPD; Unstable COPD

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.

  The primary variable (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 placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is a 14-item daily questionnaire where each item is assessed on a 5 or 6 point ordinal scale. Participants completed the EXACT questionnaire on a daily basis via an electronic diary from Day 1 (pre-dose) to Day 84 (week 12). Higher scores on the daily EXACT questionnaire indicate a more severe health state. When the post-treatment EXACT scores are lower (i.e. improved symptoms) than baseline EXACT, the AACs are positive.

  12 weeks

Secondary Outcomes (6)

• Change From Baseline in COPD Assessment Tool (CAT) Score

  12 weeks

• Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))

  12 weeks

• Time to First COPD Exacerbation

  12 weeks

• The Number of Subjects With at Least One COPD Exacerbation.

  12 weeks

• Change From Baseline in FEV1

  12 weeks

Study Arms (2)

AQX-1125

EXPERIMENTAL

1 x AQX-1125 capsule daily

Drug: AQX-1125

Placebo

PLACEBO COMPARATOR

1 x Placebo capsule daily

Drug: Placebo

Interventions

AQX-1125 DRUG

Synthetic SHIP1 activator

AQX-1125

Placebo DRUG

Placebo control

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Aquinox Pharmaceuticals (Canada) Inc.: lead

Study Sites (8)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Department of Respiratory & Sleep Medicine, Westmead Hospital

Wentworthville, New South Wales, 2145, Australia

Location

Department of Respiratory Medicine, Odense University Hospital

Odense, Denmark

Location

Biomedicum Helsinki

Helsinki, Finland

Location

Csongrád Megyei Melkasi Betegségek Szakkórháza

Deszk, Hungary

Location

P3 Research

Wellington, New Zealand

Location

Medical University of Lodz

Lodz, Poland

Location

Lung and Allergy Clinic, Skåne University Hospital

Lund, Sweden

Location

Related Links

• GOLD COPD Guidelines

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Secondary objective of "The frequency and severity of AEs and changes in physical exam, vital signs, ophthalmic exam, laboratory tests, weight, ECG, and con meds" was monitored throughout the study, clinically significant events were reported as AEs.

Results Point of Contact

• Title: Clinical
• Organization: Aquinox Pharmaceuticals (Canada) Inc.

clinical@aqxpharma.com

+1 (604) 629-9223

Study Officials

• Stephen B Shrewsbury, MD

  Aquinox Pharmaceuticals (Canada) Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); PL (1); US (1); AU (1); FI (1); HU (1); SE (1); NZ (1)