COPD, Healthy Volunteer
Conditions
Brief summary
The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.
Detailed description
This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers. The primary objective is to characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. The secondary objective is to calculate correlation of peak inspiratory flow (PIF) rate with regards to anthropometric and lung function parameters. Substudy: This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers.There will be 1 study visit per subject, usually this visit is done at the same visit with the main study.
Interventions
DRUGPlacebo Tiotropium inhalation powder type A
Placebo inhalation from inhaler A
DRUGPlacebo Spiriva capsule
Placebo inhalation from HandiHaler
DRUGPlacebo Tiotropium inhalation powder type B
Placebo inhalation from inhaler B
DEVICESubstudy Placebo Tiotropium Easyhaler
Substudy placebo inhalation
DEVICESubstudy Placebo Spiriva® via HandiHaler
Substudy placebo inhalation
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for subjects with COPD: 1. Written informed consent (IC) obtained. 2. ≥18 years of age. 3. Documented diagnosis of COPD. Inclusion Criteria for healthy volunteers: 1. Written informed consent (IC) obtained. 2. ≥18 years of age. 3. FEV1 at least 80% of the predicted value measured at screening. 4. Good general health ascertained by medical history.
Exclusion criteria
for subjects with COPD: 1. Any chronic respiratory disease other than COPD. 2. Acute respiratory infection. 3. Concurrent participation in a clinical drug study. 4. Any medical condition (e.g. contraindications to spirometry) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she participates in the study. E.g. any concomitant disease in clinically labile state judged by the investigator. 5. Severe milk allergy (lactose contains small amounts of milk proteins).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers. | 1 day | After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory volume through the Easyhaler and HandiHaler inhalers | 1 day | Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's preference of inhalers assessed by study specific questionnaire | 1 day | Substudy outcome |
| Correct use of Easyhaler and HandiHaler tabulated by frequencies and percents based on the inhaler specific questionnaire, assessed by the site staff. | 1 day | Substudy outcome |
| Peak inspiratory flow measurement via In-Check Dial | 1 day | Substudy outcome |
| Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire. | 1 day | Substudy outcome |
| Patient's acceptability of inhalers, assessed by the study specific questionnaire | 1 day | Substudy outcome |
Countries
Estonia
Outcome results
None listed