Efficacy and Safety of AQX-1125 in Unstable COPD (FLAGSHIP)
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|ClinicalTrials.gov Identifier: NCT01954628|
Recruitment Status : Completed
First Posted : October 7, 2013
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|COPD||Drug: AQX-1125 Drug: Placebo||Phase 2|
Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Acute exacerbations of COPD are usually treated with steroids and/or antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. During an acute exacerbation of COPD, the inflammation in the airways increases.
AQX-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of COPD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 2015|
1 x AQX-1125 capsule daily
Synthetic SHIP1 activator
Placebo Comparator: Placebo
1 x Placebo capsule daily
- The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. [ Time Frame: 12 weeks ]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.
- Change From Baseline in COPD Assessment Tool (CAT) Score [ Time Frame: 12 weeks ]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.The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from baseline indicates improvement. The change in total CAT score from Day 1, before taking study drug (baseline), to end of the 12 week treatment period was compared between the two treatments using an ANOVA model adjusting for treatment and region and including the baseline score as a covariate.
- Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) [ Time Frame: 12 weeks ]
The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the number of COPD exacerbations (MTE).
COPD exacerbations were referred to as Medically Treated Exacerbations (MTEs) and identified as a change in symptoms and/or signs of COPD requiring prescription of one or both of: (1) Course of oral corticosteroids or (2) Antibiotic(s).
- Time to First COPD Exacerbation [ Time Frame: 12 weeks ]The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the time to first exacerbation requiring medical intervention of oral corticosteroids and/or antibiotics.
- The Number of Subjects With at Least One COPD Exacerbation. [ Time Frame: 12 weeks ]The number of subjects that presented with a COPD exacerbation during the 12 week treatment period.
- Change From Baseline in FEV1 [ Time Frame: 12 weeks ]
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].
FEV1 was determined from post-bronchodilator spirometry testing done at clinic visits.
- AQX-1125 Concentrations in Plasma (Trough Values) [ Time Frame: 12 weeks ]The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954628
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Australia, New South Wales|
|Department of Respiratory & Sleep Medicine, Westmead Hospital|
|Wentworthville, New South Wales, Australia, 2145|
|Department of Respiratory Medicine, Odense University Hospital|
|Csongrád Megyei Melkasi Betegségek Szakkórháza|
|Wellington, New Zealand|
|Medical University of Lodz|
|Lung and Allergy Clinic, Skåne University Hospital|
|Study Director:||Stephen B Shrewsbury, MD||Aquinox Pharmaceuticals (Canada) Inc.|