EASYRELIEF: Use of Buventol Easyhaler and Bufomix Easyhaler in Methacoline Challenge Testing

Sponsor
Orion Corporation, Orion Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05084222
Collaborator
(none)
180
1
3
9.7
18.6

Study Details

Study Description

Brief Summary

The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler.

This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.

Condition or Disease Intervention/Treatment Phase
  • Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI
  • Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
  • Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles During Induced Bronchoconstriction in Adult Subjects
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Buventol® Easyhaler® 200 µg/inhalation dmDPI

400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations.

Drug: Buventol® Easyhaler® 200 µg/inhalation dmDPI
Two doses will be administered
Other Names:
  • Salbutamol 200 µg/dose dmDPI
  • Experimental: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI

    320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations.

    Drug: Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI
    Two doses will be administered
    Other Names:
  • Budesonide/formoterol 160/4.5 µg/inhalation dmDPI
  • Active Comparator: Ventoline® Evohaler® 100 µg/inhalation pMDI

    400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations.

    Drug: Ventoline® Evohaler® 100 µg/inhalation pMDI
    Four doses will be administered via Volumatic spacer
    Other Names:
  • Salbutamol 100 µg/dose MDI
  • Outcome Measures

    Primary Outcome Measures

    1. Forced expiratory volume in one second (FEV1) [10 minutes]

      Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever.

    Secondary Outcome Measures

    1. Number of subjects who recover from bronchoconstriction after first dose [10 minutes]

      Proportion of the subjects who recover to FEV1 > -10% compared to post-diluent FEV1 after first dose of reliever.

    2. Forced expiratory volume in one second (FEV1) [10 minutes]

      Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1.

    3. Number of subjects who recover from bronchoconstriction after second dose [20 minutes]

      Proportions of subjects reaching FEV1 > -10% of post-diluent value after second dose of reliever.

    Other Outcome Measures

    1. Number of patients needing medical attention [After study treatment administration until study completion (an average of 2.5 hours)]

      Proportion of subjects needing medical attention after study treatment

    2. Inhalation profile via Easyhaler [Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry]

      Time-inspiratory flow -curve via Easyhaler measured with spirometer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Written informed consent (IC) obtained.

    2. Finnish speaking adult (≥ 18 years old) subject indicated for methacholine challenge test.

    3. The subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry.

    Exclusion Criteria:
    1. Subjects not eligible for methacholine challenge test for example for any of the following reasons:
    • Any respiratory infection within 2 weeks, or severe respiratory infection within 4 weeks before the study visit

    • FEV1 < 60% of predicted or < 1.0 l

    • Inability to perform acceptable and repeatable spirometry manoeuvres throughout the test procedure

    • Uncontrolled hypertension

    • Acute chest pain or unstable angina pectoris

    • Significant cardiac arrhythmias

    • Pneumothorax or recent bronchoscopy

    • Myocardial infarction or stroke in last 3 months

    • Known aortic aneurysm

    • Recent eye surgery or intracranial pressure elevation risk

    • Cholinesterase inhibitor medication

    • Pregnant or lactating females

    1. Subjects who have used the following treatments before the study visit:
    • Short-acting β-agonists within 12 h

    • Long-acting β-agonists within 36 h

    • Ultra-long-acting β-agonists within 48 h

    • Long-acting anti-muscarinic agents within 168 h

    • Short-acting anticholinergics within 12 h

    • Oral theophylline within 24 h

    • Inhaled corticosteroids, leukotriene receptor antagonists and chromones within 4 weeks

    1. Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).

    2. Administration of another investigational medicinal product within 30 days before the study visit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tampere University Hospital Tampere Finland 33520

    Sponsors and Collaborators

    • Orion Corporation, Orion Pharma

    Investigators

    • Study Director: Iissa Kivistö, Orion Pharma, Espoo, Finland
    • Principal Investigator: Lauri Lehtimäki, Tampere University Hospital, Finland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Orion Corporation, Orion Pharma
    ClinicalTrials.gov Identifier:
    NCT05084222
    Other Study ID Numbers:
    • 0010032
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022