Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Inspiratory Flow Parameters With Placebo Tiotropium Easyhaler® and Placebo Spiriva® Capsule Via HandiHaler® in Patients With COPD and in Healthy Volunteers. Substudy: Easyhaler® and HandiHaler® Usability Study in Patients With COPD

Conditions
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Healthy Volunteer, COPD

Intervention / Treatment
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* Drug: Placebo Tiotropium inhalation powder type A
* Drug: Placebo Spiriva capsule
* Drug: Placebo Tiotropium inhalation powder type B
* Device: Substudy Placebo Tiotropium Easyhaler
* Device: Substudy Placebo Spiriva® via HandiHaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for subjects with COPD: Written informed consent (IC) obtained. ≥18 years of age. Documented diagnosis of COPD. Inclusion Criteria for healthy volunteers: Written informed consent (IC) obtained. ≥18 years of age. FEV1 at least 80% of the predicted value measured at screening. Good general health ascertained by medical history. Exclusion Criteria for subjects with COPD: Any chronic respiratory disease other than COPD. Acute respiratory infection. Concurrent participation in a clinical drug study. 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. Severe milk allergy (lactose contains small amounts of milk proteins). Exclusion Criteria for healthy volunteers: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease within the previous 2 years. Acute respiratory infection. Concurrent participation in a clinical drug study. 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. Severe milk allergy (lactose contains small amounts of milk proteins). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaler A, Tiotropium Easyhaler<br>Placebo Tiotropium Easyhaler, type A | Drug: Placebo Tiotropium inhalation powder type A<br>* Placebo inhalation from inhaler A<br>|
| Experimental: Inhaler B, Tiotropium Easyhaler<br>Placebo Tiotropium Easyhaler, type B | Drug: Placebo Tiotropium inhalation powder type B<br>* Placebo inhalation from inhaler B<br>|
| Placebo Comparator: Reference product, Spiriva modified HandiHaler<br>Placebo Spiriva, hard capsule inhaled via modified HandiHaler device | Drug: Placebo Spiriva capsule<br>* Placebo inhalation from HandiHaler<br>|
| Experimental: Substudy Test product Placebo Tiotropium Easyhaler<br>The substudy subjects will demonstrate the use of the inhaler. | Device: Substudy Placebo Tiotropium Easyhaler<br>* Substudy placebo inhalation<br>|
| Placebo Comparator: Substudy Reference product Placebo Spiriva® HandiHaler<br>The substudy subjects will demonstrate the use of the inhaler. | Device: Substudy Placebo Spiriva® via HandiHaler<br>* Substudy placebo inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |