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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaler A, Tiotropium Easyhaler | Experimental | Placebo Tiotropium Easyhaler, type A |
|
| Inhaler B, Tiotropium Easyhaler | Experimental | Placebo Tiotropium Easyhaler, type B |
|
| Reference product, Spiriva modified HandiHaler | Placebo Comparator | Placebo Spiriva, hard capsule inhaled via modified HandiHaler device |
|
| Substudy Test product Placebo Tiotropium Easyhaler | Experimental | The substudy subjects will demonstrate the use of the inhaler. |
|
| Substudy Reference product Placebo Spiriva® HandiHaler | Placebo Comparator | The substudy subjects will demonstrate the use of the inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Tiotropium inhalation powder type A | Drug | Placebo inhalation from inhaler A |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers. | After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory volume through the Easyhaler and HandiHaler inhalers | Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Correct use of Easyhaler and HandiHaler tabulated by frequencies and percents based on the inhaler specific questionnaire, assessed by the site staff. | Substudy outcome | 1 day |
| Patient's acceptability of inhalers, assessed by the study specific questionnaire |
Inclusion Criteria for subjects with COPD:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria for subjects with COPD:
Exclusion Criteria for healthy volunteers:
Substudy:
Patients with documented diagnosis of COPD aged 18 year or older participating the main study will be enrolled in this substudy. Written informed consent (IC) will be obtained.
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| Name | Affiliation | Role |
|---|---|---|
| Orion Pharma Clinical Study Director | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lung Clinic, Tartu University Hospital | Tartu | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38170393 | Derived | Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3. |
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| Placebo Spiriva capsule | Drug | Placebo inhalation from HandiHaler |
|
| Placebo Tiotropium inhalation powder type B | Drug | Placebo inhalation from inhaler B |
|
| Substudy Placebo Tiotropium Easyhaler | Device | Substudy placebo inhalation |
|
| Substudy Placebo Spiriva® via HandiHaler | Device | Substudy placebo inhalation |
|
Substudy outcome
| 1 day |
| Patient's preference of inhalers assessed by study specific questionnaire | Substudy outcome | 1 day |
| Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire. | Substudy outcome | 1 day |
| Peak inspiratory flow measurement via In-Check Dial | Substudy outcome | 1 day |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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