Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation

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

Investigating nasal muco-ciliary clearance by scintigraphy

Study Overview

• Status: Unknown
• Conditions: Obstructive Airway Diseases
• Intervention / Treatment: Device: Inhalation from a salt particle inhaler with or without content

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 31
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zainab Saraj, Cand.Pharm.; Phone Number: 0045 22268865; Email: zs@liitacare.com

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Clin nuclear and physiolog dept.
    • Contact: Jann Mortensen, MD Professor; Phone Number: +45 3545 4011; Email: Jann.Mortensen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Liita Care ApS

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: LC.002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No