Trial · NCT03615040
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Where a COPD exacerbation is defined by symptomatic worsening of COPD requiring: * Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or * Use of antibiotics and/or * inpatient hospitalisation or death due to COPD |
| Secondary | Adverse Event Rate in the 48 Weeks of the Trial From First Dose | Weeks 0 , 4, 12, 24, 26, 48 | Number of Participants with Adverse Events in the 48 Weeks of the Trial From First Dose |
| Secondary | Serious Adverse Event Rate in the 48 Weeks of the Trial From First Dose | Weeks 0 , 4, 12, 24, 26, 48 | Number of Participants with Serious Adverse Events in the 48 Weeks of the Trial From First Dose |
| Secondary | St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score | Weeks 0, 4, 12, 24, 36, 48 | Patient reported outcome (PRO). To evaluate health status; designed to measure health impairment in patients with asthma and COPD. It is in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impact scores. A Total score is also produced. The Total score is calculated by summing the weights to all the positive responses in each component. This score is then put onto the scale 0 to 100 by dividing by the Total possible sum (3201.9)- and times by 100. A score of 0 would represent the best health and a score of 100 would represent the worst possible state of the patient. |
| Secondary | COPD Assessment Test (CAT) (Questionnaire) | Weeks 0, 4, 12, 24, 36, 48 | Patient reported outcome (PRO). To evaluate health status: evaluation and rehabilitation education guidance on the respiratory and motor functions of patients with chronic obstructive pulmonary disease. CAT score is made by summing the score to eight questions on COPD. For each, the person with COPD picks the number between 0-5 that reflects their response. A zero indicates no effect on quality of life, whereas a 5 suggests a very significant effect.The CAT has a scoring range of 0-40, with 40 indicating the most severe COPD and 0 being the least severe COPD. A change of 2 units suggests a meaningful difference. This test should be used in conjunction with the mMRC and forced expiratory volume in one second (FEV1) to determine COPD health assessment of participants. |
| Secondary | Modified Medical Research Council (mMRC) Dyspnea Scale | Screening, weeks 0, 4, 12, 24, 36, 48 | Patient reported outcome (PRO). To evaluate respiratory breathlessness symptoms (Grade 0-4, with Grade 0 being breathlessness with strenuous exercise to Grade 4 being breathlessness for daily activities like dressing). |
| Secondary | Visual Analogue Score (VAS) Total and Individual Dyspnoea, Cough, Sputum Production (100mm) Scores | Weeks 0, 4, 12, 24, 36, 48 | Patient reported outcome (PRO). To evaluate respiratory symptoms. The participant is asked to place a mark (X) on the scale at the point that best describes their health currently. Minimum score 0mm (better outcome), maximum score 100mm (worse outcome) for each section of the scale (dyspnoea, cough, sputum). The Total VAS score is the sum of the 3 scales, thus the minimum score is 0 (best outcome) and the maximum 300 (worst outcome). |
| Secondary | Sputum Purulence Colour Card | Screening, week 12, 28, 36, 48 | The sputum purulence colour card using the Bronko test has values of 0, 1, 2, 3, 4, 5 and 6. Lower scores indicate better health. |
| Secondary | Pre and Post Bronchodilator (BD) Spirometry - FEV1/FVC Ratio | Week 0 and Week 48 | To assess lung function. The participant will take a maximum inhalation, release maximum exhalation and then continue to exhale afterwards. They will then be treated with a bronchodilator. The spirometry test is then repeated to determine how much the bronchodilator medication helped with breathing. FEV1/FVC ratio will be calculated. |
| Secondary | Post BD Forced Expiratory Volume in 1 Second (FEV1) | Screening, Weeks 4, 12, 24, 36, 48 | To assess lung function. FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration. Post BD Forced Expiratory Volume in 1 Second (FEV1) |
| Secondary | Body Plethysmography ('Body Box') Total Lung Capacity and Residual Volume | Week 0 and week 48 | To assess lung function, i.e. the functional residual capacity of the lungs. The participant sits inside an airtight box, inhales or exhales to a particular volume (usually FRC), and then a shutter drops across their breathing tube. The participant makes respiratory efforts against the closed shutter, causing their chest volume to expand and decompressing the air in their lungs. The increase in their chest volume slightly reduces the box volume (the non-person volume of the box) and thus slightly increases the pressure in the box. Total Lung Capacity and Residual Volume measured. |
| Secondary | Blood Inflammatory Cell Differentials | Weeks 0, 4, 12, 24, 36, 48 | To assess inflammation at exacerbation events. White blood cells, eosinophils and neutrophils will be measured. |
| Secondary | Sputum Inflammatory Cell Differentials: Eosinophils | Weeks 0, 4, 12, 24, 36, 48 | To assess inflammation at exacerbation events. Eosinophils cells will be measured. |
| Secondary | Pre and Post Bronchodilator (BD) Spirometry- FEV1 and FVC | Week 0 and Week 48 | To assess lung function. The participant will take a maximum inhalation, release maximum exhalation and then continue to exhale afterwards. They will then be treated with a bronchodilator. The spirometry test is then repeated to determine how much the bronchodilator medication helped with breathing. FEV1 and FVC will be measured. |
| Secondary | Pre and Post Bronchodilator (BD) Spirometry- FEV1 Predicted and FVC Predicted | Week 0 and Week 48 | To assess lung function. The participant will take a maximum inhalation, release maximum exhalation and then continue to exhale afterwards. They will then be treated with a bronchodilator. The spirometry test is then repeated to determine how much the bronchodilator medication helped with breathing. FEV1 % predicted and FVC % predicted will be measured. |
| Secondary | Body Plethysmography ('Body Box') - Residual Volume/Total Lung Capacity Ratio | Week 0 and week 48 | To assess lung function, i.e. the functional residual capacity of the lungs. The participant sits inside an airtight box, inhales or exhales to a particular volume (usually FRC), and then a shutter drops across their breathing tube. The participant makes respiratory efforts against the closed shutter, causing their chest volume to expand and decompressing the air in their lungs. The increase in their chest volume slightly reduces the box volume (the non-person volume of the box) and thus slightly increases the pressure in the box. Residual Volume/Total Lung Capacity ratio will be calculated. RV/TLC ratio: this is the residual volume (RV) to total lung capacity (TLC). It is calculated as a percentage as follows: RV/TLC ×100. |
| Secondary | Sputum Inflammatory Cell Differentials: Macrophages | Weeks 0, 4, 12, 24, 36, 48 | To assess inflammation at exacerbation events. Sputum inflammatory cell differentials: Macrophages |
| Secondary | Sputum Inflammatory Cell Differentials: Epithelium | Weeks 0, 4, 12, 24, 36, 48 | To assess inflammation at exacerbation events. Epithelium cells will be measured. |
| Other | Non-contrast Thoracic CT Derived Outcomes [Exploratory Outcome] | Screening and week 48 | Quantitative measures of airway geometry and densitometry. Mean lung density expiratory/inspiratory \[MLD E/I\] (small airway), % wall area \[WA\] and LA (larger airways) will be measured. |
| Other | Sputum Mediator Profiling (Biomarkers) [Exploratory Outcome] | Weeks 0, 4, 12, 24, 36, 48 | Various biomarkers of inflammation will be measured in sputum. |
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.
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