Phase 2
Completed N=400
Efficacy and Safety of AQX-1125 in Unstable COPD
Source: ClinicalTrials.gov NCT01954628 ↗Enrolled (actual)
400
Serious AEs
4.5%
Results posted
Jun 2017
Primary outcomePrimary: The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. — 415.4; 391.7 Area Above Curve on Daily Exact Score — p=0.759
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. |
415.4; 391.7 | 0.759 |
| SECONDARY Change From Baseline in COPD Assessment Tool (CAT) Score |
-4.05; -3.71 | 0.588 |
| SECONDARY Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) |
1.776; 1.641 | 0.646 |
| SECONDARY Time to First COPD Exacerbation |
38.1; 43.9 | — |
| SECONDARY The Number of Subjects With at Least One COPD Exacerbation. |
48; 51 | — |
| SECONDARY Change From Baseline in FEV1 |
-0.02; 0.01 | 0.226 |
| SECONDARY AQX-1125 Concentrations in Plasma (Trough Values) |
170.1; 163.9; 120.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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 3 weeks to stabilise
Data sourced from ClinicalTrials.gov (NCT01954628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.