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

Orion Pharma

Status: Completed

Conditions: Healthy Volunteer; COPD

Treatments: Device: Substudy Placebo Spiriva® via HandiHaler; Drug: Placebo Tiotropium inhalation powder type B; Device: Substudy Placebo Tiotropium Easyhaler; Drug: Placebo Spiriva capsule; Drug: Placebo Tiotropium inhalation powder type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04147572

3122004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 5 patient groups, including a placebo group

Inhaler A, Tiotropium Easyhaler

Experimental group

Description:

Placebo Tiotropium Easyhaler, type A

Treatment:

Drug: Placebo Tiotropium inhalation powder type A

Inhaler B, Tiotropium Easyhaler

Experimental group

Description:

Placebo Tiotropium Easyhaler, type B

Treatment:

Drug: Placebo Tiotropium inhalation powder type B

Reference product, Spiriva modified HandiHaler

Placebo Comparator group

Description:

Placebo Spiriva, hard capsule inhaled via modified HandiHaler device

Treatment:

Drug: Placebo Spiriva capsule

Substudy Test product Placebo Tiotropium Easyhaler

Experimental group

Description:

The substudy subjects will demonstrate the use of the inhaler.

Treatment:

Device: Substudy Placebo Tiotropium Easyhaler

Substudy Reference product Placebo Spiriva® HandiHaler

Placebo Comparator group

Description:

The substudy subjects will demonstrate the use of the inhaler.

Treatment:

Device: Substudy Placebo Spiriva® via HandiHaler