Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation

Study Overview
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Brief Summary
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Investigating nasal muco-ciliary clearance by scintigraphy

Detailed Description
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The velocity and the retention of the nasal muco-ciliary clearance is going to be investigated with a salt particle inhaler and a placebo by the method nasal scintigraphy. The hypotheses is that nasal inhalation of salt particles enhance the nasal mucociliary clearance.

Official Title
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Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation Via a Salt Particle Inhaler at COPD, Asthma and Healthy Individuals

Conditions
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Obstructive Airway Diseases

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 patients (all severities in chronic, stable condition) Asthma patients (in stable condition without acute asthma symptoms) Healthy subjects, incl. smokers (no chronic nasal, upper or lower respiratory diseases) Exclusion Criteria: Age under 18 years Upper respiratory tract infection / cold within the last 3 weeks and at least 3 weeks must pass from the person has become well to the examination Allergic / non-allergic rhinitis (hay fever) Chronic sinusitis Acute respiratory tract infection in antibiotic therapy Applied salt inhalation within the past month Pregnant or breastfeeding women Nuclear medical examination within the past month Cannot taste saccharin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


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 |
| --- | --- | --- |
| Nasal Mucociliary Clearance | Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation | At study day 1 and 2 | 
| Nasal Mucociliary Clearance | Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation | At study day 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry | Change in FEV! from placebo to saltinhalation | At the beginning and the end of study day 1 and 2 | 
| Saccharin test | Change in time for saccharin transport | At study day 1 and 2 |