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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01954628
Registration number
NCT01954628
Ethics application status
Date submitted
21/09/2013
Date registered
7/10/2013
Titles & IDs
Public title
Efficacy and Safety of AQX-1125 in Unstable COPD
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Scientific 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
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Secondary ID [1]
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AQX-1125-202
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Universal Trial Number (UTN)
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Trial acronym
FLAGSHIP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AQX-1125
Treatment: Drugs - Placebo
Experimental: AQX-1125 - 1 x AQX-1125 capsule daily
Placebo comparator: Placebo - 1 x Placebo capsule daily
Treatment: Drugs: AQX-1125
Synthetic SHIP1 activator
Treatment: Drugs: Placebo
Placebo control
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Change From Baseline in COPD Assessment Tool (CAT) Score
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))
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Assessment method [2]
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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).
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Time to First COPD Exacerbation
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Assessment method [3]
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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.
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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The Number of Subjects With at Least One COPD Exacerbation.
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Assessment method [4]
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The number of subjects that presented with a COPD exacerbation during the 12 week treatment period.
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Change From Baseline in FEV1
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Assessment method [5]
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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.
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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AQX-1125 Concentrations in Plasma (Trough Values)
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Assessment method [6]
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The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma.
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Timepoint [6]
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12 weeks
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Department of Respiratory & Sleep Medicine, Westmead Hospital - Wentworthville
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Recruitment postcode(s) [1]
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2145 - Wentworthville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Ohio
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Country [2]
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Denmark
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State/province [2]
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Odense
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Country [3]
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Finland
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State/province [3]
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Helsinki
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Country [4]
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Hungary
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State/province [4]
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Deszk
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Country [5]
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New Zealand
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State/province [5]
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Wellington
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Country [6]
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Poland
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State/province [6]
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Lodz
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Country [7]
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Sweden
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State/province [7]
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Lund
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Aquinox Pharmaceuticals (Canada) Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01954628
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen B Shrewsbury, MD
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Address
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Aquinox Pharmaceuticals (Canada) Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01954628