Obstructive Airway DiseasesNCT04189016
Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation
A study testing Inhalation from a salt particle inhaler with or without content in people with Obstructive Airway Diseases, run by Liita Care ApS at 1 site in Denmark.
Trial summary
Investigating nasal muco-ciliary clearance by scintigraphy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Airway Diseases
- What is being tested?
- Inhalation from a salt particle inhaler with or without content
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Pregnant or breastfeeding women
- Nuclear medical examination within the past month
- Cannot taste saccharin
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Clin nuclear and physiolog dept.
Copenhagen, 2100
Jann Mortensen, MD Professor, +45 3545 4011, Jann.Mortensen@regionh.dk
About this study
Official title: 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
Read the 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.
- Conditions
- Obstructive Airway Diseases
- Being tested
- Inhalation from a salt particle inhaler with or without content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation from a salt particle inhaler with or without contentDevice
Inhalation from inhaler with (active) or without (placebo) content
| Study group | Role | What they receive |
|---|---|---|
| Salt particle inhaler with content | Active comparator | Participants inhaling from a salt particle inhaler with content Receives: Device: Inhalation from a salt particle inhaler with or without content |
| Salt particle inhaler without content | Placebo comparator | Participants inhaling from a salt particle inhaler without content Receives: Device: Inhalation from a salt particle inhaler with or without content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Mucociliary Clearance
Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation
Measured: At study day 1 and 2
Nasal Mucociliary Clearance
Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation
Measured: At study day 1 and 2
Secondary outcomes (2)
Spirometry
Change in FEV! from placebo to saltinhalation
Measured: At the beginning and the end of study day 1 and 2
Saccharin test
Change in time for saccharin transport
Measured: At study day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study startFeb 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Airway DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liita Care ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189016
- Sponsor's protocol ID
- LC.002
- Status last verified
- Jan 2021
- First submitted
- 28 Nov 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation Via a Salt Particle Inhaler at COPD, Asthma and Healthy Individuals
- ClinicalTrials.gov ID
- NCT04189016
- Acronym / sponsor ID
- LC.002
- Conditions
- Obstructive Airway Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Liita Care ApSIndustry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salt particle inhaler with content | Active comparator | Device: Inhalation from a salt particle inhaler with or without contentParticipants inhaling from a salt particle inhaler with content |
| Salt particle inhaler without content | Placebo comparator | Device: Inhalation from a salt particle inhaler with or without contentParticipants inhaling from a salt particle inhaler without content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation from a salt particle inhaler with or without contentInhalation from inhaler with (active) or without (placebo) content | Device | Salt particle inhaler with content, Salt particle inhaler without content |
Primary outcome
Nasal Mucociliary Clearance
Time frame: At study day 1 and 2
Change in nasal mucociliary clearance velocity (mm/min) from placebo to salt inhalation
Nasal Mucociliary Clearance
Time frame: At study day 1 and 2
Change in nasal mucociliary clearance retention (%) from placebo to salt inhalation
2 secondary outcomes
Spirometry
Time frame: At the beginning and the end of study day 1 and 2
Saccharin test
Time frame: At study day 1 and 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation from a salt particle inhaler with or without content in people with Obstructive Airway Diseases, run by Liita Care ApS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zainab Saraj, Cand.Pharm. (0045 22268865, zs@liitacare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Mucociliary Clearance (time frame: At study day 1 and 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.