Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
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ClinicalTrials.gov Identifier: NCT03927365 |
Recruitment Status :
Suspended
(COVID-19 Pandemic)
First Posted : April 25, 2019
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD Copd Bronchitis | Device: Inhalation from a salt particle inhaler with or without content | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Participants cross over from active to placebo or vice versa in random order |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Randomization of a salt particle inhaler devices with (active) or without (placebo) content |
Primary Purpose: | Treatment |
Official Title: | Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler |
Actual Study Start Date : | October 1, 2018 |
Estimated Primary Completion Date : | April 2021 |
Estimated Study Completion Date : | May 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Salt particle inhaler with content
Participants inhaling from a salt particle inhaler with content
|
Device: Inhalation from a salt particle inhaler with or without content
Inhalation from inhaler with (active) or without (placebo) content |
Placebo Comparator: Salt particle inhaler without content
Participants inhaling from a salt particle inhaler without content
|
Device: Inhalation from a salt particle inhaler with or without content
Inhalation from inhaler with (active) or without (placebo) content |
- Muco-ciliary clearance [ Time Frame: Activity at time zero ]Retention of inhaled radioactive marker in percentage
- Muco-ciliary clearance [ Time Frame: Activity at time 30 minutes ]Retention of inhaled radioactive marker in percentage
- Muco-ciliary clearance [ Time Frame: Activity at time 90 minutes ]Retention of inhaled radioactive marker in percentage
- Muco-ciliary clearance [ Time Frame: Activity at time 120 minutes ]Retention of inhaled radioactive marker in percentage
- Registering number of coughs [ Time Frame: Activity at any time between time zero and 120 minutes ]Number of coughs during investigation is noted
- Collection of sputum [ Time Frame: Activity at any time between time zero and 120 minutes ]Sputum during investigation is collected for analysis of radioactivity content
- Symptoms in the subjects health [ Time Frame: Activity at time zero ]Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)
- Symptoms in the subjects health [ Time Frame: Activity at time 30 ]Subjective symptom description during investigation is done by a questionnaire
- Symptoms in the subjects health [ Time Frame: Activity at time 120 ]Subjective symptom description during investigation is done by a questionnaire

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927365
Denmark | |
Rigshospitalet, Clin nuclear and physiolog dept. | |
Copenhagen, Denmark, 2100 |
Principal Investigator: | Jann Mortensen, MD Professor | Rigshospitalet, Clin Nuclear & Physiolog dept. |
Responsible Party: | Liita Care ApS |
ClinicalTrials.gov Identifier: | NCT03927365 |
Other Study ID Numbers: |
LC.001 |
First Posted: | April 25, 2019 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bronchitis Lung Diseases, Obstructive Lung Diseases |
Respiratory Tract Diseases Bronchial Diseases Respiratory Tract Infections |