NCT04147572

Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer
• COPD

Interventions

Type	Name	Description
DRUG	Placebo Tiotropium inhalation powder type A	Placebo inhalation from inhaler A
DRUG	Placebo Spiriva capsule	Placebo inhalation from HandiHaler
DRUG	Placebo Tiotropium inhalation powder type B	Placebo inhalation from inhaler B
DEVICE	Substudy Placebo Tiotropium Easyhaler	Substudy placebo inhalation
DEVICE	Substudy Placebo Spiriva® via HandiHaler	Substudy placebo inhalation

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-01-13
• Completion: 2020-01-13
• First posted: 2019-11-01
• Last updated: 2020-01-27

Locations

1 site across 1 country: Estonia