Back to results

Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler (TIOPIF)

Primary Purpose

Healthy Volunteer, COPD

Status

Completed

Phase

Not Applicable

Locations

Estonia

Study Type

Interventional

Intervention

Placebo Tiotropium inhalation powder type A

Placebo Spiriva capsule

Placebo Tiotropium inhalation powder type B

Substudy Placebo Tiotropium Easyhaler

Substudy Placebo Spiriva® via HandiHaler

About this trial

This is an interventional basic science trial for Healthy Volunteer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for subjects with COPD:

Written informed consent (IC) obtained.
≥18 years of age.
Documented diagnosis of COPD.

Inclusion Criteria for healthy volunteers:

Written informed consent (IC) obtained.
≥18 years of age.
FEV1 at least 80% of the predicted value measured at screening.
Good general health ascertained by medical history.

Exclusion Criteria for subjects with COPD:

Any chronic respiratory disease other than COPD.
Acute respiratory infection.
Concurrent participation in a clinical drug study.
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.
Severe milk allergy (lactose contains small amounts of milk proteins).

Exclusion Criteria for healthy volunteers:

Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease within the previous 2 years.
Acute respiratory infection.
Concurrent participation in a clinical drug study.
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.
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.

Sites / Locations

Lung Clinic, Tartu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Inhaler A, Tiotropium Easyhaler

Inhaler B, Tiotropium Easyhaler

Reference product, Spiriva modified HandiHaler

Substudy Test product Placebo Tiotropium Easyhaler

Substudy Reference product Placebo Spiriva® HandiHaler

Arm Description

Placebo Tiotropium Easyhaler, type A

Placebo Tiotropium Easyhaler, type B

Placebo Spiriva, hard capsule inhaled via modified HandiHaler device

The substudy subjects will demonstrate the use of the inhaler.

Outcomes

Primary Outcome Measures

The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.

After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.

Secondary Outcome Measures

Inspiratory volume through the Easyhaler and HandiHaler inhalers

Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.

Full Information

NCT ID

NCT04147572

First Posted

October 25, 2019

Last Updated

January 23, 2020

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04147572

Brief Title

Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

Acronym

TIOPIF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

January 13, 2020 (Actual)

Study Completion Date

January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteer, COPD

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaler A, Tiotropium Easyhaler

Arm Type

Experimental

Arm Description

Placebo Tiotropium Easyhaler, type A

Arm Title

Inhaler B, Tiotropium Easyhaler

Arm Type

Experimental

Arm Description

Placebo Tiotropium Easyhaler, type B

Arm Title

Reference product, Spiriva modified HandiHaler

Arm Type

Placebo Comparator

Arm Description

Placebo Spiriva, hard capsule inhaled via modified HandiHaler device

Arm Title

Substudy Test product Placebo Tiotropium Easyhaler

Arm Type

Experimental

Arm Description

The substudy subjects will demonstrate the use of the inhaler.

Arm Title

Substudy Reference product Placebo Spiriva® HandiHaler

Arm Type

Placebo Comparator

Arm Description

The substudy subjects will demonstrate the use of the inhaler.

Intervention Type

Drug

Intervention Name(s)

Placebo Tiotropium inhalation powder type A

Intervention Description

Placebo inhalation from inhaler A

Intervention Type

Drug

Intervention Name(s)

Placebo Spiriva capsule

Intervention Description

Placebo inhalation from HandiHaler

Intervention Type

Drug

Intervention Name(s)

Placebo Tiotropium inhalation powder type B

Intervention Description

Placebo inhalation from inhaler B

Intervention Type

Device

Intervention Name(s)

Substudy Placebo Tiotropium Easyhaler

Intervention Description

Substudy placebo inhalation

Intervention Type

Device

Intervention Name(s)

Substudy Placebo Spiriva® via HandiHaler

Intervention Description

Substudy placebo inhalation

Primary Outcome Measure Information:

Title

The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.

Description

After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Inspiratory volume through the Easyhaler and HandiHaler inhalers

Description

Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.

Time Frame

1 day

Other Pre-specified Outcome Measures:

Title

Correct use of Easyhaler and HandiHaler tabulated by frequencies and percents based on the inhaler specific questionnaire, assessed by the site staff.

Description

Substudy outcome

Time Frame

1 day

Title

Patient's acceptability of inhalers, assessed by the study specific questionnaire

Description

Substudy outcome

Time Frame

1 day

Title

Patient's preference of inhalers assessed by study specific questionnaire

Description

Substudy outcome

Time Frame

1 day

Title

Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire.

Description

Substudy outcome

Time Frame

1 day

Title

Peak inspiratory flow measurement via In-Check Dial

Description

Substudy outcome

Time Frame

1 day

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for subjects with COPD: Written informed consent (IC) obtained. ≥18 years of age. Documented diagnosis of COPD. Inclusion Criteria for healthy volunteers: Written informed consent (IC) obtained. ≥18 years of age. FEV1 at least 80% of the predicted value measured at screening. Good general health ascertained by medical history. Exclusion Criteria for subjects with COPD: Any chronic respiratory disease other than COPD. Acute respiratory infection. Concurrent participation in a clinical drug study. 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. Severe milk allergy (lactose contains small amounts of milk proteins). Exclusion Criteria for healthy volunteers: Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease within the previous 2 years. Acute respiratory infection. Concurrent participation in a clinical drug study. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Orion Pharma Clinical Study Director

Organizational Affiliation

Orion Corporation, Orion Pharma

Official's Role

Study Director

Facility Information:

Facility Name

Lung Clinic, Tartu University Hospital

City

Tartu

Country

Estonia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

We'll reach out to this number within 24 hrs