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Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

NCT04147572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-01-27

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer
  • COPD

Interventions

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Orion Pharma Clinical Study Director · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-01-13
Completion
2020-01-13

Countries

  • Estonia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147572 on ClinicalTrials.gov