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

Not Applicable

Suspended

• Conditions: COPD; Copd Bronchitis
• Interventions: Device: Inhalation from a salt particle inhaler with or without content

• Registration Number: NCT03927365
• Lead Sponsor: Liita Care ApS

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-04
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salt particle inhaler with content	Inhalation from a salt particle inhaler with or without content	Participants inhaling from a salt particle inhaler with content
Salt particle inhaler without content	Inhalation from a salt particle inhaler with or without content	Participants inhaling from a salt particle inhaler without content

Primary Outcome Measures

Name	Time	Method
Muco-ciliary clearance	Activity at time 120 minutes	Retention of inhaled radioactive marker in percentage

Secondary Outcome Measures

Name	Time	Method
Registering number of coughs	Activity at any time between time zero and 120 minutes	Number of coughs during investigation is noted
Collection of sputum	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	Activity at time 120	Subjective symptom description during investigation is done by a questionnaire

Trial Locations

Locations (1)

Rigshospitalet, Clin nuclear and physiolog dept.; 🇩🇰 Copenhagen, Denmark