Inspiratory Flow Parameters With Placebo Easyhaler and Placebo HandiHaler

Overview

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 Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 13, 2020

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.

Interventions

  • Drug: Placebo Tiotropium inhalation powder type A
    • Placebo inhalation from inhaler A
  • Drug: Placebo Spiriva capsule
    • Placebo inhalation from HandiHaler
  • Drug: Placebo Tiotropium inhalation powder type B
    • Placebo inhalation from inhaler B
  • Device: Substudy Placebo Tiotropium Easyhaler
    • Substudy placebo inhalation
  • Device: Substudy Placebo Spiriva® via HandiHaler
    • Substudy placebo inhalation

Arms, Groups and Cohorts

  • Experimental: Inhaler A, Tiotropium Easyhaler
    • Placebo Tiotropium Easyhaler, type A
  • Experimental: Inhaler B, Tiotropium Easyhaler
    • Placebo Tiotropium Easyhaler, type B
  • Placebo Comparator: Reference product, Spiriva modified HandiHaler
    • Placebo Spiriva, hard capsule inhaled via modified HandiHaler device
  • Experimental: Substudy Test product Placebo Tiotropium Easyhaler
    • The substudy subjects will demonstrate the use of the inhaler.
  • Placebo Comparator: Substudy Reference product Placebo Spiriva® HandiHaler
    • The substudy subjects will demonstrate the use of the inhaler.

Clinical Trial Outcome Measures

Primary Measures

  • The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
    • Time Frame: 1 day
    • After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Orion Corporation, Orion Pharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Orion Pharma Clinical Study Director, Study Director, Orion Corporation, Orion Pharma

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