Clincosm LogoSign in Get a demo

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

Sponsor
Liita Care ApS (Industry)
Overall Status
Suspended
CT.gov ID
NCT03927365
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase
  • Device: Inhalation from a salt particle inhaler with or without content
 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
Anticipated Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants cross over from active to placebo or vice versa in random orderParticipants 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 :
Oct 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 1, 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 [Activity at time zero]

    Retention of inhaled radioactive marker in percentage

  2. Muco-ciliary clearance [Activity at time 30 minutes]

    Retention of inhaled radioactive marker in percentage

  3. Muco-ciliary clearance [Activity at time 90 minutes]

    Retention of inhaled radioactive marker in percentage

  4. Muco-ciliary clearance [Activity at time 120 minutes]

    Retention of inhaled radioactive marker in percentage

Secondary Outcome Measures

  1. Registering number of coughs [Activity at any time between time zero and 120 minutes]

    Number of coughs during investigation is noted

  2. Collection of sputum [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 [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 [Activity at time 30]

    Subjective symptom description during investigation is done by a questionnaire

  5. Symptoms in the subjects health [Activity at time 120]

    Subjective symptom description during investigation is done by a questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rigshospitalet, Clin nuclear and physiolog dept. Copenhagen Denmark 2100

Sponsors and Collaborators

  • Liita Care ApS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liita Care ApS
ClinicalTrials.gov Identifier:
NCT03927365
Other Study ID Numbers:
  • LC.001
First Posted:
Apr 25, 2019
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Jan 15, 2021