Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler

Conditions
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COPD, Copd Bronchitis

Intervention / Treatment
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* Device: Inhalation from a salt particle inhaler with or without content


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits Exclusion Criteria: Pregnant or lactating women Patients exposed to radionuclear isotopes within one month Patients under antibiotic treatment Patients with known hyper reactive airways
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants cross over from active to placebo or vice versa in random order
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Salt particle inhaler with content<br>Participants inhaling from a salt particle inhaler with content | Device: Inhalation from a salt particle inhaler with or without content<br>* Inhalation from inhaler with (active) or without (placebo) content<br>|
| Placebo Comparator: Salt particle inhaler without content<br>Participants inhaling from a salt particle inhaler without content | Device: Inhalation from a salt particle inhaler with or without content<br>* Inhalation from inhaler with (active) or without (placebo) content<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |