Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

• Status: Completed
• Trial end date: 2020-01-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Tiotropium Bromide

Criteria

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).

Exclusion Criteria for healthy volunteers:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease within the previous 2 years.

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.

5. 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.