Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation

Obstructive Airway Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04189016
• Other study ID #: LC.002
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: September 2021

Study information

• Verified date: January 2021
• Source: Liita Care ApS
• Contact: Zainab Saraj, Cand.Pharm.
• Phone: 0045 22268865
• Email: zs[@]liitacare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating nasal muco-ciliary clearance by scintigraphy

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases, Obstructive
• Obstructive Airway Diseases

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	Nasal Mucociliary Clearance	Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation	At study day 1 and 2
Primary	Nasal Mucociliary Clearance	Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation	At study day 1 and 2
Secondary	Spirometry	Change in FEV! from placebo to saltinhalation	At the beginning and the end of study day 1 and 2
Secondary	Saccharin test	Change in time for saccharin transport	At study day 1 and 2