Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

NCT ID: NCT04147572

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-01-13

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.

Conditions

Healthy Volunteer; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Inhaler A, Tiotropium Easyhaler

Placebo Tiotropium Easyhaler, type A

Group Type: EXPERIMENTAL

Placebo Tiotropium inhalation powder type A

Intervention Type: DRUG

Placebo inhalation from inhaler A

Inhaler B, Tiotropium Easyhaler

Placebo Tiotropium Easyhaler, type B

Group Type: EXPERIMENTAL

Placebo Tiotropium inhalation powder type B

Intervention Type: DRUG

Placebo inhalation from inhaler B

Reference product, Spiriva modified HandiHaler

Placebo Spiriva, hard capsule inhaled via modified HandiHaler device

Group Type: PLACEBO_COMPARATOR

Placebo Spiriva capsule

Intervention Type: DRUG

Placebo inhalation from HandiHaler

Substudy Test product Placebo Tiotropium Easyhaler

The substudy subjects will demonstrate the use of the inhaler.

Group Type: EXPERIMENTAL

Substudy Placebo Tiotropium Easyhaler

Intervention Type: DEVICE

Substudy placebo inhalation

Substudy Reference product Placebo Spiriva® HandiHaler

The substudy subjects will demonstrate the use of the inhaler.

Group Type: PLACEBO_COMPARATOR

Substudy Placebo Spiriva® via HandiHaler

Intervention Type: DEVICE

Substudy placebo inhalation

Interventions

Placebo Tiotropium inhalation powder type A

Placebo inhalation from inhaler A

Intervention Type: DRUG

Placebo Spiriva capsule

Placebo inhalation from HandiHaler

Intervention Type: DRUG

Placebo Tiotropium inhalation powder type B

Placebo inhalation from inhaler B

Intervention Type: DRUG

Substudy Placebo Tiotropium Easyhaler

Substudy placebo inhalation

Intervention Type: DEVICE

Substudy Placebo Spiriva® via HandiHaler

Substudy placebo inhalation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Written informed consent (IC) obtained.

2. ≥18 years of age.

3. Documented diagnosis of COPD.

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

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Orion Pharma Clinical Study Director

Role: STUDY_DIRECTOR

Orion Corporation, Orion Pharma

Locations

Lung Clinic, Tartu University Hospital

Tartu, , Estonia

Countries

Estonia

References

Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.

Reference Type: DERIVED

PMID: 38170393 (View on PubMed)

Other Identifiers

3122004

Identifier Type: -

Identifier Source: org_study_id