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

Liita Care

Status: Suspended

Conditions: Copd Bronchitis; COPD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03927365

LC.001

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Salt particle inhaler with content

Active Comparator group

Description:

Participants inhaling from a salt particle inhaler with content

Treatment:

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

Salt particle inhaler without content

Placebo Comparator group

Description:

Participants inhaling from a salt particle inhaler without content

Treatment:

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