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COVID-19 Pandemic
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Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.
Stable COPD patients will be examined twice with minimum two, maximum 14 days interval. In randomized order the patients will inhale from a salt particle inhaler with (active) or without (placebo) content.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salt particle inhaler with content | Active Comparator | Participants inhaling from a salt particle inhaler with content |
|
| Salt particle inhaler without content | Placebo Comparator | Participants inhaling from a salt particle inhaler without content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhalation from a salt particle inhaler with or without content | Device | Inhalation from inhaler with (active) or without (placebo) content |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muco-ciliary clearance | Retention of inhaled radioactive marker in percentage | Activity at time zero |
| Muco-ciliary clearance | Retention of inhaled radioactive marker in percentage | Activity at time 30 minutes |
| Muco-ciliary clearance | Retention of inhaled radioactive marker in percentage | Activity at time 90 minutes |
| Muco-ciliary clearance | Retention of inhaled radioactive marker in percentage | Activity at time 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Registering number of coughs | Number of coughs during investigation is noted | Activity at any time between time zero and 120 minutes |
| Collection of sputum | Sputum during investigation is collected for analysis of radioactivity content |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jann Mortensen, MD Professor | Rigshospitalet, Clin Nuclear & Physiolog dept. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Clin nuclear and physiolog dept. | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Participants cross over from active to placebo or vice versa in random order
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Randomization of a salt particle inhaler devices with (active) or without (placebo) content
| Activity at any time between time zero and 120 minutes |
| Symptoms in the subjects health | Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire) | Activity at time zero |
| Symptoms in the subjects health | Subjective symptom description during investigation is done by a questionnaire | Activity at time 30 |
| Symptoms in the subjects health | Subjective symptom description during investigation is done by a questionnaire | Activity at time 120 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |