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

NCT03927365 | Suspended

• 1 other identifier: LC.001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Copd Bronchitis

Outcome Measures

Primary Outcomes (4)

• Muco-ciliary clearance

  Retention of inhaled radioactive marker in percentage

  Activity at time zero

• Muco-ciliary clearance

  Retention of inhaled radioactive marker in percentage

  Activity at time 30 minutes

• Muco-ciliary clearance

  Retention of inhaled radioactive marker in percentage

  Activity at time 90 minutes

• Muco-ciliary clearance

  Retention of inhaled radioactive marker in percentage

  Activity at time 120 minutes

Secondary Outcomes (5)

• Registering number of coughs

  Activity at any time between time zero and 120 minutes

• Collection of sputum

  Activity at any time between time zero and 120 minutes

• Symptoms in the subjects health

  Activity at time zero

• Symptoms in the subjects health

  Activity at time 30

• Symptoms in the subjects health

  Activity at time 120

Study Arms (2)

Salt particle inhaler with content

ACTIVE COMPARATOR

Participants inhaling from a salt particle inhaler with content

Device: Inhalation from a salt particle inhaler with or without content

Salt particle inhaler without content

PLACEBO COMPARATOR

Participants inhaling from a salt particle inhaler without content

Device: Inhalation from a salt particle inhaler with or without content

Interventions

Inhalation from a salt particle inhaler with or without content DEVICE

Inhalation from inhaler with (active) or without (placebo) content

Salt particle inhaler with content; Salt particle inhaler without content

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits

You may not qualify if:

• Pregnant or lactating women
• Patients exposed to radionuclear isotopes within one month
• Patients under antibiotic treatment
• Patients with known hyper reactive airways

Sponsors & Collaborators

• Liita Care ApS: lead

Study Sites (1)

Rigshospitalet, Clin nuclear and physiolog dept.

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jann Mortensen, MD Professor

  Rigshospitalet, Clin Nuclear & Physiolog dept.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization of a salt particle inhaler devices with (active) or without (placebo) content
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants cross over from active to placebo or vice versa in random order

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: April 25, 2019
• Study Start: October 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)