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Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927365
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Liita Care ApS

Study Description
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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.

Condition or disease Intervention/treatment Phase
COPD Copd Bronchitis Device: Inhalation from a salt particle inhaler with or without content Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants cross over from active to placebo or vice versa in random order
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization of a salt particle inhaler devices with (active) or without (placebo) content
Primary Purpose: Treatment
Official Title: Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Muco-ciliary clearance [ Time Frame: Activity at time zero ]
    Retention of inhaled radioactive marker in percentage

  2. Muco-ciliary clearance [ Time Frame: Activity at time 30 minutes ]
    Retention of inhaled radioactive marker in percentage

  3. Muco-ciliary clearance [ Time Frame: Activity at time 90 minutes ]
    Retention of inhaled radioactive marker in percentage

  4. Muco-ciliary clearance [ Time Frame: Activity at time 120 minutes ]
    Retention of inhaled radioactive marker in percentage


Secondary Outcome Measures :
  1. Registering number of coughs [ Time Frame: Activity at any time between time zero and 120 minutes ]
    Number of coughs during investigation is noted

  2. Collection of sputum [ Time Frame: Activity at any time between time zero and 120 minutes ]
    Sputum during investigation is collected for analysis of radioactivity content

  3. Symptoms in the subjects health [ Time Frame: Activity at time zero ]
    Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire)

  4. Symptoms in the subjects health [ Time Frame: Activity at time 30 ]
    Subjective symptom description during investigation is done by a questionnaire

  5. Symptoms in the subjects health [ Time Frame: Activity at time 120 ]
    Subjective symptom description during investigation is done by a questionnaire


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927365


Contacts
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Contact: Jann Mortensen, MD Professor +45 3545 4011 Jann.Mortensen@regionh.dk
Contact: Zainab Saraj, Cand.Pharm +45 22 26 88 65 zs@liitacare.com

Locations
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Denmark
Rigshospitalet, Clin nuclear and physiolog dept. Recruiting
Copenhagen, Denmark, 2100
Contact: Jann Mortensen, MD Professor    +45 3545 4011    Jann.Mortensen@regionh.dk   
Sponsors and Collaborators
Liita Care ApS
Investigators
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Principal Investigator: Jann Mortensen, MD Professor Rigshospitalet, Clin Nuclear & Physiolog dept.
More Information
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Responsible Party: Liita Care ApS
ClinicalTrials.gov Identifier: NCT03927365    
Other Study ID Numbers: LC.001
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchitis
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections