Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

Not Applicable

Completed

• Conditions: Healthy Volunteer; COPD
• Interventions: Drug: Placebo Tiotropium inhalation powder type B; Drug: Placebo Tiotropium inhalation powder type A; Drug: Placebo Spiriva capsule; Device: Substudy Placebo Spiriva® via HandiHaler; Device: Substudy Placebo Tiotropium Easyhaler

• Registration Number: NCT04147572
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-29
• Study Start: 2019-11-01
• Study First Posted: 2019-11-01
• Status Verified: 2020-01
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Inhaler B, Tiotropium Easyhaler	Placebo Tiotropium inhalation powder type B	Placebo Tiotropium Easyhaler, type B
Inhaler A, Tiotropium Easyhaler	Placebo Tiotropium inhalation powder type A	Placebo Tiotropium Easyhaler, type A
Reference product, Spiriva modified HandiHaler	Placebo Spiriva capsule	Placebo Spiriva, hard capsule inhaled via modified HandiHaler device
Substudy Reference product Placebo Spiriva® HandiHaler	Substudy Placebo Spiriva® via HandiHaler	The substudy subjects will demonstrate the use of the inhaler.
Substudy Test product Placebo Tiotropium Easyhaler	Substudy Placebo Tiotropium Easyhaler	The substudy subjects will demonstrate the use of the inhaler.

Primary Outcome Measures

Name	Time	Method
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.	1 day	After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.

Secondary Outcome Measures

Name	Time	Method
Inspiratory volume through the Easyhaler and HandiHaler inhalers	1 day	Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.

Trial Locations

Locations (1)

Lung Clinic, Tartu University Hospital; 🇪🇪 Tartu, Estonia