Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

COPD Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147572
• Other study ID #: 3122004
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: January 13, 2020

Study information

• Verified date: January 2020
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for subjects with COPD:

1. Written informed consent (IC) obtained.

2. =18 years of age.

3. Documented diagnosis of COPD.

Inclusion Criteria for healthy volunteers:

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 for subjects with COPD:

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).

Exclusion Criteria for healthy volunteers:

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.

Related Conditions & MeSH terms

• COPD
• Healthy Volunteer
• Respiratory Aspiration

Intervention

Drug:
• Placebo Tiotropium inhalation powder type A
Placebo inhalation from inhaler A
• Placebo Spiriva capsule
Placebo inhalation from HandiHaler
• Placebo Tiotropium inhalation powder type B
Placebo inhalation from inhaler B

Device:
• Substudy Placebo Tiotropium Easyhaler
Substudy placebo inhalation
• Substudy Placebo Spiriva® via HandiHaler
Substudy placebo inhalation

Locations

Country	Name	City	State
Estonia	Lung Clinic, Tartu University Hospital	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correct use of Easyhaler and HandiHaler tabulated by frequencies and percents based on the inhaler specific questionnaire, assessed by the site staff.	Substudy outcome	1 day
Other	Patient's acceptability of inhalers, assessed by the study specific questionnaire	Substudy outcome	1 day
Other	Patient's preference of inhalers assessed by study specific questionnaire	Substudy outcome	1 day
Other	Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire.	Substudy outcome	1 day
Other	Peak inspiratory flow measurement via In-Check Dial	Substudy outcome	1 day
Primary	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.	1 day
Secondary	Inspiratory volume through the Easyhaler and HandiHaler inhalers	Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.	1 day