Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

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.

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.