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

NCT ID: NCT03927365

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-05-31

Brief Summary

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Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.

Detailed Description

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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.

Conditions

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COPD Copd Bronchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants cross over from active to placebo or vice versa in random order
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Randomization of a salt particle inhaler devices with (active) or without (placebo) content

Study Groups

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Salt particle inhaler with content

Participants inhaling from a salt particle inhaler with content

Group Type ACTIVE_COMPARATOR

Inhalation from a salt particle inhaler with or without content

Intervention Type DEVICE

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

Salt particle inhaler without content

Participants inhaling from a salt particle inhaler without content

Group Type PLACEBO_COMPARATOR

Inhalation from a salt particle inhaler with or without content

Intervention Type DEVICE

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

Interventions

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Inhalation from a salt particle inhaler with or without content

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liita Care ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jann Mortensen, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Clin Nuclear & Physiolog dept.

Locations

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Rigshospitalet, Clin nuclear and physiolog dept.

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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LC.001

Identifier Type: -

Identifier Source: org_study_id

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