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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; COPD
• Intervention / Treatment: Drug: Placebo Tiotropium inhalation powder type A; Drug: Placebo Tiotropium inhalation powder type B; Drug: Placebo Spiriva capsule; Device: Substudy Placebo Tiotropium Easyhaler; Device: Substudy Placebo Spiriva® via HandiHaler

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia
    • Lung Clinic, Tartu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaler A, Tiotropium Easyhaler; Placebo Tiotropium Easyhaler, type A	Drug: Placebo Tiotropium inhalation powder type A; Placebo inhalation from inhaler A
Experimental: Inhaler B, Tiotropium Easyhaler; Placebo Tiotropium Easyhaler, type B	Drug: Placebo Tiotropium inhalation powder type B; Placebo inhalation from inhaler B
Placebo Comparator: Reference product, Spiriva modified HandiHaler; Placebo Spiriva, hard capsule inhaled via modified HandiHaler device	Drug: Placebo Spiriva capsule; Placebo inhalation from HandiHaler
Experimental: Substudy Test product Placebo Tiotropium Easyhaler; The substudy subjects will demonstrate the use of the inhaler.	Device: Substudy Placebo Tiotropium Easyhaler; Substudy placebo inhalation
Placebo Comparator: Substudy Reference product Placebo Spiriva® HandiHaler; The substudy subjects will demonstrate the use of the inhaler.	Device: Substudy Placebo Spiriva® via HandiHaler; Substudy placebo inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory volume through the Easyhaler and HandiHaler inhalers	Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient's acceptability of inhalers, assessed by the study specific questionnaire	Substudy outcome	1 day
Patient's preference of inhalers assessed by study specific questionnaire	Substudy outcome	1 day
Patient's ability to learn the use of the inhalers, assessed by the study specific questionnaire.	Substudy outcome	1 day
Peak inspiratory flow measurement via In-Check Dial	Substudy outcome	1 day

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma
• Investigators: Study Director: Orion Pharma Clinical Study Director, Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): January 13, 2020
• Study Completion (Actual): January 13, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 3122004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No