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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03927365
• Other study ID #: LC.001
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 2021

Study information

• Verified date: January 2021
• Source: Liita Care ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 35
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchitis
• COPD
• Copd Bronchitis

Intervention

Device:
• Inhalation from a salt particle inhaler with or without content
Inhalation from inhaler with (active) or without (placebo) content

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Clin nuclear and physiolog dept.	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Liita Care ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muco-ciliary clearance	Retention of inhaled radioactive marker in percentage	Activity at time zero
Primary	Muco-ciliary clearance	Retention of inhaled radioactive marker in percentage	Activity at time 30 minutes
Primary	Muco-ciliary clearance	Retention of inhaled radioactive marker in percentage	Activity at time 90 minutes
Primary	Muco-ciliary clearance	Retention of inhaled radioactive marker in percentage	Activity at time 120 minutes
Secondary	Registering number of coughs	Number of coughs during investigation is noted	Activity at any time between time zero and 120 minutes
Secondary	Collection of sputum	Sputum during investigation is collected for analysis of radioactivity content	Activity at any time between time zero and 120 minutes
Secondary	Symptoms in the subjects health	Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)	Activity at time zero
Secondary	Symptoms in the subjects health	Subjective symptom description during investigation is done by a questionnaire	Activity at time 30
Secondary	Symptoms in the subjects health	Subjective symptom description during investigation is done by a questionnaire	Activity at time 120