COPD, Copd Bronchitis
Conditions
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.
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.
Interventions
Inhalation from inhaler with (active) or without (placebo) content
Sponsors
Liita Care ApS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization of a salt particle inhaler devices with (active) or without (placebo) content
Intervention model description
Participants cross over from active to placebo or vice versa in random order
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muco-ciliary clearance | Activity at time zero | Retention of inhaled radioactive marker in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Registering number of coughs | Activity at any time between time zero and 120 minutes | Number of coughs during investigation is noted |
| Collection of sputum | Activity at any time between time zero and 120 minutes | Sputum during investigation is collected for analysis of radioactivity content |
| Symptoms in the subjects health | Activity at time zero | Subjective symptom description during last 24 hours is done by a CCQ (Clinical COPD Questionnaire) |
Countries
Denmark
Outcome results
None listed