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

January 13, 2021 updated by: Liita Care ApS
Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Clin nuclear and physiolog dept.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muco-ciliary clearance
Time Frame: Activity at time zero
Retention of inhaled radioactive marker in percentage
Activity at time zero
Muco-ciliary clearance
Time Frame: Activity at time 30 minutes
Retention of inhaled radioactive marker in percentage
Activity at time 30 minutes
Muco-ciliary clearance
Time Frame: Activity at time 90 minutes
Retention of inhaled radioactive marker in percentage
Activity at time 90 minutes
Muco-ciliary clearance
Time Frame: Activity at time 120 minutes
Retention of inhaled radioactive marker in percentage
Activity at time 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registering number of coughs
Time Frame: Activity at any time between time zero and 120 minutes
Number of coughs during investigation is noted
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
Sputum during investigation is collected for analysis of radioactivity content
Activity at any time between time zero and 120 minutes
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)
Activity at time zero
Symptoms in the subjects health
Time Frame: Activity at time 30
Subjective symptom description during investigation is done by a questionnaire
Activity at time 30
Symptoms in the subjects health
Time Frame: Activity at time 120
Subjective symptom description during investigation is done by a questionnaire
Activity at time 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liita Care ApS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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