Back to resultsMuco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Primary Purpose
COPD, Copd Bronchitis
Status
Suspended
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 treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits
Exclusion Criteria:
- Pregnant or lactating women
- Patients exposed to radionuclear isotopes within one month
- Patients under antibiotic treatment
- Patients with known hyper reactive airways
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
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Muco-ciliary clearance
Retention of inhaled radioactive marker in percentage
Secondary Outcome Measures
Registering number of coughs
Number of coughs during investigation is noted
Collection of sputum
Sputum during investigation is collected for analysis of radioactivity content
Symptoms in the subjects health
Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)
Symptoms in the subjects health
Subjective symptom description during investigation is done by a questionnaire
Symptoms in the subjects health
Subjective symptom description during investigation is done by a questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03927365
Brief Title
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Official Title
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 Pandemic
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
May 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
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Copd Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants cross over from active to placebo or vice versa in random order
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization of a salt particle inhaler devices with (active) or without (placebo) content
Allocation
Randomized
Enrollment
35 (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
Muco-ciliary clearance
Description
Retention of inhaled radioactive marker in percentage
Time Frame
Activity at time zero
Title
Muco-ciliary clearance
Description
Retention of inhaled radioactive marker in percentage
Time Frame
Activity at time 30 minutes
Title
Muco-ciliary clearance
Description
Retention of inhaled radioactive marker in percentage
Time Frame
Activity at time 90 minutes
Title
Muco-ciliary clearance
Description
Retention of inhaled radioactive marker in percentage
Time Frame
Activity at time 120 minutes
Secondary Outcome Measure Information:
Title
Registering number of coughs
Description
Number of coughs during investigation is noted
Time Frame
Activity at any time between time zero and 120 minutes
Title
Collection of sputum
Description
Sputum during investigation is collected for analysis of radioactivity content
Time Frame
Activity at any time between time zero and 120 minutes
Title
Symptoms in the subjects health
Description
Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)
Time Frame
Activity at time zero
Title
Symptoms in the subjects health
Description
Subjective symptom description during investigation is done by a questionnaire
Time Frame
Activity at time 30
Title
Symptoms in the subjects health
Description
Subjective symptom description during investigation is done by a questionnaire
Time Frame
Activity at time 120
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits
Exclusion Criteria:
Pregnant or lactating women
Patients exposed to radionuclear isotopes within one month
Patients under antibiotic treatment
Patients with known hyper reactive airways
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jann Mortensen, MD Professor
Organizational Affiliation
Rigshospitalet, Clin Nuclear & Physiolog dept.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Clin nuclear and physiolog dept.
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
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