Back to resultsNasal Muco-ciliary Clearance Study With and Without Salt Inhalation
Primary Purpose
Obstructive Airway Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Inhalation from a salt particle inhaler with or without content
Sponsored by
About this trial
This is an interventional other trial for Obstructive Airway Diseases
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet, Clin nuclear and physiolog dept.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Salt particle inhaler with content
Salt particle inhaler without content
Arm Description
Participants inhaling from a salt particle inhaler with content
Participants inhaling from a salt particle inhaler without content
Outcomes
Primary Outcome Measures
Nasal Mucociliary Clearance
Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation
Nasal Mucociliary Clearance
Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation
Secondary Outcome Measures
Spirometry
Change in FEV! from placebo to saltinhalation
Saccharin test
Change in time for saccharin transport
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04189016
Brief Title
Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation
Official Title
Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation Via a Salt Particle Inhaler at COPD, Asthma and Healthy Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liita Care ApS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigating nasal muco-ciliary clearance by scintigraphy
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Airway Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Salt particle inhaler with content
Arm Type
Active Comparator
Arm Description
Participants inhaling from a salt particle inhaler with content
Arm Title
Salt particle inhaler without content
Arm Type
Placebo Comparator
Arm Description
Participants inhaling from a salt particle inhaler without content
Intervention Type
Device
Intervention Name(s)
Inhalation from a salt particle inhaler with or without content
Intervention Description
Inhalation from inhaler with (active) or without (placebo) content
Primary Outcome Measure Information:
Title
Nasal Mucociliary Clearance
Description
Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation
Time Frame
At study day 1 and 2
Title
Nasal Mucociliary Clearance
Description
Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation
Time Frame
At study day 1 and 2
Secondary Outcome Measure Information:
Title
Spirometry
Description
Change in FEV! from placebo to saltinhalation
Time Frame
At the beginning and the end of study day 1 and 2
Title
Saccharin test
Description
Change in time for saccharin transport
Time Frame
At study day 1 and 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Saraj, Cand.Pharm.
Phone
0045 22268865
Email
zs@liitacare.com
Facility Information:
Facility Name
Rigshospitalet, Clin nuclear and physiolog dept.
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jann Mortensen, MD Professor
Phone
+45 3545 4011
Email
Jann.Mortensen@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation
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