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

  • Clinicaltrials.gov identifier

    NCT03927365

  • Recruitment Status

    Suspended (COVID-19 Pandemic)

  • First Posted

    April 25, 2019

  • Last update posted

    January 15, 2021

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.

  • Condition or Disease:COPD
    Copd Bronchitis
  • Intervention/Treatment: Device: Inhalation from a salt particle inhaler with or without content
  • Phase: N/A

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

  • Study Type: Interventional
  • 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)
  • Primary Purpose: Treatment
  • Official Title: Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: May 2021

Arms and interventions

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

  • 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

  • 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

Contacts

Locations

Denmark
Rigshospitalet, Clin nuclear and physiolog dept.
Copenhagen

Sponsors and Collaborators

Liita Care ApS

Investigators

Principal Investigator: Jann Mortensen, MD Professor Rigshospitalet, Clin Nuclear & Physiolog dept.

More Information

  • Responsible Party: Liita Care ApS
  • ClinicalTrials.gov Identifier: NCT03927365 History of Changes
  • Other Study ID Numbers: LC.001
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: January 15, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Bronchitis