COPDNCT03927365
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
A study testing Inhalation from a salt particle inhaler with or without content in people with COPD and Copd Bronchitis, run by Liita Care ApS at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Copd Bronchitis
- 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
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits
Who cannot join
- Pregnant or lactating women
- Patients exposed to radionuclear isotopes within one month
- Patients under antibiotic treatment
- Patients with known hyper reactive airways
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Clin nuclear and physiolog dept.
Copenhagen, 2100
About this study
Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.
Read the 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.
- Conditions
- COPD, Copd Bronchitis
- Being tested
- Inhalation from a salt particle inhaler with or without content
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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.
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Measured: Activity at time zero
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Measured: Activity at time 30 minutes
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Measured: Activity at time 90 minutes
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Measured: Activity at time 120 minutes
Secondary outcomes (5)
Registering number of coughs
Number of coughs during investigation is noted
Measured: Activity at any time between time zero and 120 minutes
Collection of sputum
Sputum during investigation is collected for analysis of radioactivity content
Measured: Activity at any time between time zero and 120 minutes
Symptoms in the subjects health
Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)
Measured: Activity at time zero
Symptoms in the subjects health
Subjective symptom description during investigation is done by a questionnaire
Measured: Activity at time 30
Symptoms in the subjects health
Subjective symptom description during investigation is done by a questionnaire
Measured: Activity at time 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Oct 2018
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants cross over from active to placebo or vice versa in random order
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liita Care ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jann Mortensen, MD Professor, Principal investigator, Rigshospitalet, Clin Nuclear & Physiolog dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927365
- Sponsor's protocol ID
- LC.001
- Status last verified
- Jan 2021
- First submitted
- 1 Oct 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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
- Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
- ClinicalTrials.gov ID
- NCT03927365
- Acronym / sponsor ID
- LC.001
- Conditions
- COPD, Copd Bronchitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19 Pandemic
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Liita Care ApSIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 25 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants cross over from active to placebo or vice versa in random order
| 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
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Patients exposed to radionuclear isotopes within one month
- Patients under antibiotic treatment
- Patients with known hyper reactive airways
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
Muco-ciliary clearance
Time frame: Activity at time zero
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Time frame: Activity at time 30 minutes
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Time frame: Activity at time 90 minutes
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Time frame: Activity at time 120 minutes
Retention of inhaled radioactive marker in percentage
5 secondary outcomes
Registering number of coughs
Time frame: Activity at any time between time zero and 120 minutes
Collection of sputum
Time frame: Activity at any time between time zero and 120 minutes
Symptoms in the subjects health
Time frame: Activity at time zero
Symptoms in the subjects health
Time frame: Activity at time 30
Symptoms in the subjects health
Time frame: Activity at time 120
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.
Jann Mortensen, MD Professor principal investigator
Rigshospitalet, Clin Nuclear & Physiolog dept.
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 COPD and Copd Bronchitis, 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 1 inclusion and 4 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: paused, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muco-ciliary clearance (time frame: Activity at time zero). The study lists 4 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; AzTrials last refreshed its copy on 7 Nov 2026.