Trial · NCT03615040
Outcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Moderate to Severe Exacerbation (Defined as Requiring Treatment With Systemic Corticosteroids and/or Antibiotics in the Community or Hospital or Hospitalisation). | 0-48 weeks | An intention-to-treat population was used for the primary analysis and all participants were included in the analysis (n = 81). The primary analysis used observed data, meaning only observed exacerbations were used alongside the corresponding time period in the offset of log-time. | Exacerbations | MEAN |
| SECONDARY | Adverse Event Rate in the 48 Weeks of the Trial From First Dose | Weeks 0 , 4, 12, 24, 26, 48 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose | Weeks 0 , 4, 12, 24, 26, 48 | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | score on a scale | MEAN |
| SECONDARY | COPD Assessment Test (CAT) (Questionnaire) | Weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | score on a scale | MEAN |
| SECONDARY | Modified Medical Research Council (mMRC) Dyspnea Scale | Screening, weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | score on a scale | MEDIAN |
| SECONDARY | Visual Analogue Score (VAS) Total and Individual Dyspnoea, Cough, Sputum Production (100mm) Scores | Weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | units on a scale | MEAN |
| SECONDARY | Sputum Purulence Colour Card | Screening, week 12, 28, 36, 48 | Modified ITT (available data) | score on a scale | MEDIAN |
| SECONDARY | Pre and Post Bronchodilator (BD) Spirometry - FEV1/FVC Ratio | Week 0 and Week 48 | Modified ITT (available data) | Ratio | MEAN |
| SECONDARY | Post BD Forced Expiratory Volume in 1 Second (FEV1) | Screening, Weeks 4, 12, 24, 36, 48 | Modified ITT (available data) | Litres | MEAN |
| SECONDARY | Body Plethysmography ('Body Box') Total Lung Capacity and Residual Volume | Week 0 and week 48 | Modified ITT (available data) | Litres | MEAN |
| SECONDARY | Blood Inflammatory Cell Differentials | Weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | 10^9 *cells* per litre | GEOMETRIC_MEAN |
| SECONDARY | Sputum Inflammatory Cell Differentials: Eosinophils | Weeks 0, 4, 12, 24, 36, 48 | Modified ITT (available data) | Percentage of Eosinophils in sputum | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Non-contrast Thoracic CT Derived Outcomes [Exploratory Outcome] | Screening and week 48 | |||
| OTHER_PRE_SPECIFIED | Sputum Mediator Profiling (Biomarkers) [Exploratory Outcome] | Weeks 0, 4, 12, 24, 36, 48 | |||
| OTHER_PRE_SPECIFIED | Blood Biomarkers [Exploratory Outcome] | Screening, weeks 4, 12, 24, 36, 48 | |||
| OTHER_PRE_SPECIFIED | Cell Subset Analysis Including But Not Restricted to Exploration of ILC2 Cells [Exploratory Outcome] | Screening, weeks 4, 12, 24, 36, 48 | |||
| OTHER_PRE_SPECIFIED | Urine Biomarkers of Inflammation [Exploratory Outcome] | Screening, weeks 0, 4, 12, 24, 36, 48 | |||
| OTHER_PRE_SPECIFIED | Mediator Profiling (Biomarkers) [Exploratory Outcome] | Weeks 0, 4, 12, 24, 36, 48 | |||
| OTHER_PRE_SPECIFIED | Nasosorption [Exploratory Outcome] | Screening, Weeks 12, 24, 36, 48 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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