Clinical trial NCT04147572: Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler
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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
COPD
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
timeFrame: 1 day
Secondary outcomes:
measure: Inspiratory volume through the Easyhaler and HandiHaler inhalers
timeFrame: 1 day
Other outcomes:
measure: Correct use of Easyhaler and HandiHaler tabulated by frequencies and percents based on the inhaler specific questionnaire, assessed by the site staff.
timeFrame: 1 day
measure: Patient's acceptability of inhalers, assessed by the study specific questionnaire
timeFrame: 1 day
measure: Patient's preference of inhalers assessed by study specific questionnaire
timeFrame: 1 day
measure: Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire.
timeFrame: 1 day
measure: Peak inspiratory flow measurement via In-Check Dial
timeFrame: 1 day
Locations:
city: Tartu
country: Estonia
facility: Lung Clinic, Tartu University Hospital
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Pharma Clinical Study Director
role: STUDY_DIRECTOR
References: