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grant was withdrawn no financial support to conduct the study.
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| Name | Class |
|---|---|
| Galen Limited | INDUSTRY |
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This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.
60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.
The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erdosteine | Experimental | standard care plus erdosteine for 10 days |
|
| placebo | Placebo Comparator | Standard care for exacerbation of COPD plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erdosteine | Drug | capsule 300mg twice daily for 10 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 hr cough recording | The primary objective is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measureing differerrence in hourly cough rate from baseline (Day 0) and Day 5 of treatment, compared with standard care plus placebo | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life questionnaire | QOL questionnaire score,Compare differece in scores recorded at baseline (day 0) and day 10, compare the difference between erdosteine plus standard care with that of standard care plus placebo. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alyn H Morice, FRCP | Hull and east Yorkshire NHS trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Castle Hill Hospital | Cottingham | East Yorkshire | HU16 5JQ | United Kingdom |
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| Placebo | Drug | placebo capsule, twice daily for 10 days |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003371 | Cough |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C048498 | erdosteine |
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