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Trial record 1 of 1 for:    01954628
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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
Sponsor:
Information provided by (Responsible Party):
Aquinox Pharmaceuticals (Canada) Inc.

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.

Condition or disease Intervention/treatment Phase
COPD Drug: AQX-1125 Drug: Placebo Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AQX-1125
1 x AQX-1125 capsule daily
Drug: AQX-1125
Synthetic SHIP1 activator

Placebo Comparator: Placebo
1 x Placebo capsule daily
Drug: Placebo
Placebo control




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).


  3. 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.

  4. 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.

  5. 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.


  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Denmark
Department of Respiratory Medicine, Odense University Hospital
Odense, Denmark
Finland
Biomedicum Helsinki
Helsinki, Finland
Hungary
Csongrád Megyei Melkasi Betegségek Szakkórháza
Deszk, Hungary
New Zealand
P3 Research
Wellington, New Zealand
Poland
Medical University of Lodz
Lodz, Poland
Sweden
Lung and Allergy Clinic, Skåne University Hospital
Lund, Sweden
Sponsors and Collaborators
Aquinox Pharmaceuticals (Canada) Inc.
Investigators
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Study Director: Stephen B Shrewsbury, MD Aquinox Pharmaceuticals (Canada) Inc.
Additional Information:
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Responsible Party: Aquinox Pharmaceuticals (Canada) Inc.
ClinicalTrials.gov Identifier: NCT01954628    
Other Study ID Numbers: AQX-1125-202
First Posted: October 7, 2013    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aquinox Pharmaceuticals (Canada) Inc.:
Exacerbation of COPD
Unstable COPD
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases