Trial · NCT01954628
Efficacy and Safety of AQX-1125 in Unstable COPD
NCT01954628, Phase 2, Completed, Aquinox Pharmaceuticals (Canada) Inc.; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of AQX-1125 in Unstable COPD. Trials, record NCT01954628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01954628
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AQX-1125 in Unstable COPD
- NCT number
- NCT01954628
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 400 participants, actual
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Conditions
- COPD
- Interventions
- AQX-1125, Placebo
- First posted
- 2013-10-07
- Last updated
- 2017-06-12
- Results first posted
- 2017-06-12
- Limitations and caveats
Secondary objective of The frequency and severity of AEs and changes in physical exam, vital signs, ophthalmic exam, laboratory tests, weight, ECG, and con meds was monitored throughout the study, clinically significant events were reported as AEs.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. | 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 | Change From Baseline in COPD Assessment Tool (CAT) Score | 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. |
| Secondary | Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) | 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). |
| Secondary | Time to First COPD Exacerbation | 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. |
| Secondary | The Number of Subjects With at Least One COPD Exacerbation. | 12 weeks | The number of subjects that presented with a COPD exacerbation during the 12 week treatment period. |
| Secondary | Change From Baseline in FEV1 | 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. |
| Secondary | AQX-1125 Concentrations in Plasma (Trough Values) | 12 weeks | The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. | 12 weeks | Full Analysis Set (FAS). The FAS was all randomized subjects who have received at least one dose of the study drug and had at least one efficacy assessment (valid diary entries) post-baseline. Imputation, the mean of the last 5 days, counted backwards from day of last recording, in the treatment period will be used. | Area Above Curve on Daily Exact Score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in COPD Assessment Tool (CAT) Score | 12 weeks | Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle. | COPD Assessment Tool Score | LEAST_SQUARES_MEAN |
| SECONDARY | Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) | 12 weeks | Full analysis set was used and analyzed using the negative binomial regression model with fixed factors treatment, region and time in study as offset. Adjusted means for treatment group shows number of exacerbations/year. | Number of exacerbations/year | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First COPD Exacerbation | 12 weeks | Full analysis set | day(s) | MEAN |
| SECONDARY | The Number of Subjects With at Least One COPD Exacerbation. | 12 weeks | Full analysis set. | participants | NUMBER |
| SECONDARY | Change From Baseline in FEV1 | 12 weeks | Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle. | Liter | LEAST_SQUARES_MEAN |
| SECONDARY | AQX-1125 Concentrations in Plasma (Trough Values) | 12 weeks | PK Population | micrograms per Liter | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. | AQX-1125 (200mg) | 415.4 | 95% Confidence Interval 290.7 to 540.1 | Area Above Curve on Daily Exact Score | |
| The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period. | Placebo | 391.7 | 95% Confidence Interval 268.2 to 515.1 | Area Above Curve on Daily Exact Score | |
| Change From Baseline in COPD Assessment Tool (CAT) Score | AQX-1125 (200 mg) | -4.05 | 95% Confidence Interval -5.06 to -3.04 | COPD Assessment Tool Score | |
| Change From Baseline in COPD Assessment Tool (CAT) Score | Placebo | -3.71 | 95% Confidence Interval -4.71 to -2.71 | COPD Assessment Tool Score | |
| Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) | AQX-1125 (200 mg) | 1.776 | 95% Confidence Interval 1.374 to 2.297 | Number of exacerbations/year | |
| Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE)) | Placebo | 1.641 | 95% Confidence Interval 1.261 to 2.135 | Number of exacerbations/year | |
| Time to First COPD Exacerbation | AQX-1125 (200 mg) | 38.1 | Standard Deviation 21.3 | day(s) | |
| Time to First COPD Exacerbation | Placebo | 43.9 | Standard Deviation 24.1 | day(s) | |
| The Number of Subjects With at Least One COPD Exacerbation. | AQX-1125 (200 mg) | 48 | participants | ||
| The Number of Subjects With at Least One COPD Exacerbation. | Placebo | 51 | participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AQX-1125 (200 mg) | 200 | |
| Overall Study | STARTED | Placebo | 200 | |
| Overall Study | Full Analysis Set (FAS) | AQX-1125 (200 mg) | 200 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 198 | |
| Overall Study | Safety Set | AQX-1125 (200 mg) | 200 | |
| Overall Study | Safety Set | Placebo | 200 | |
| Overall Study | Pharmacokinetic Population | AQX-1125 (200 mg) | 181 | |
| Overall Study | Pharmacokinetic Population | Placebo | 0 | |
| Overall Study | US 6 Month Ophthalmology Safety Visit | AQX-1125 (200 mg) | 37 | |
| Overall Study | US 6 Month Ophthalmology Safety Visit | Placebo | 32 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | AQX-1125 | 11 | 200 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 200 | 9 |
| other | Headache | Nervous system disorders | AQX-1125 | 12 | 200 | 12 |
| other | Headache | Nervous system disorders | Placebo | 13 | 200 | 14 |
| serious | Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | AQX-1125 | 1 | 200 | 1 |
| serious | Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Placebo | 8 | 200 | 9 |
| serious | Pneumonia | Infections and infestations | AQX-1125 | 3 | 200 | 3 |
| serious | Pneumonia | Infections and infestations | Placebo | 2 | 200 | 2 |
| serious | Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | AQX-1125 | 2 | 200 | 2 |
| serious | Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 200 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AQX-1125 | 1 | 200 |
| Total, all-cause mortality | Placebo | 1 | 200 |
| Total, other adverse events | AQX-1125 | 21 | 200 |
| Total, other adverse events | Placebo | 21 | 200 |
| Total, serious adverse events | AQX-1125 | 6 | 200 |
| Total, serious adverse events | Placebo | 12 | 200 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AQX-1125 vs Placebo: deaths from any cause | Trial comparisons |
| AQX-1125 (200 mg) vs Placebo: The Number of Subjects With at Least One COPD Exacerbation. | Trial comparisons |
| AQX-1125 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01954628
GET https://conductscience.org/api/trials/v1/NCT01954628/registered