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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
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
Secondary ID [1] 0 0
AQX-1125-202
Universal Trial Number (UTN)
Trial acronym
FLAGSHIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Change From Baseline in COPD Assessment Tool (CAT) Score
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Time to First COPD Exacerbation
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
The Number of Subjects With at Least One COPD Exacerbation.
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Change From Baseline in FEV1
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
AQX-1125 Concentrations in Plasma (Trough Values)
Timepoint [6] 0 0
12 weeks

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
Accrual to date
Final
400
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Department of Respiratory & Sleep Medicine, Westmead Hospital - Wentworthville
Recruitment postcode(s) [1] 0 0
2145 - Wentworthville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Ohio
Country [2] 0 0
Denmark
State/province [2] 0 0
Odense
Country [3] 0 0
Finland
State/province [3] 0 0
Helsinki
Country [4] 0 0
Hungary
State/province [4] 0 0
Deszk
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington
Country [6] 0 0
Poland
State/province [6] 0 0
Lodz
Country [7] 0 0
Sweden
State/province [7] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Aquinox Pharmaceuticals (Canada) Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen B Shrewsbury, MD
Address 0 0
Aquinox Pharmaceuticals (Canada) Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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