Use of Buventol and Bufomix Easyhaler in methacholine challenge and their effect on inhalation profiles in experimentally induced asthma attacks

Use of Buventol Easyhaler and Bufomix Easyhaler as Relievers in Methacholine Challenge Testing and Inspiratory Flow Profiles during Induced Bronchoconstriction in Adult Subjects - EASYRELIEF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001573-22-FI

Enrollment

180

Registered

2021-06-17

Start date

2021-08-17

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Buventol® Easyhaler® 200 µg/dose inhalation powder Product Name: Buventol® Easyhaler® 200 µg/dose inhalation powder Pharmaceutical Form: Inhalation powder INN or Proposed INN: salbutamol C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent (IC) obtained. 2. Finnish speaking adult (= 18 years old) subject indicated for MC test. 3. The subject experiences forced expired volume in 1 second (FEV1) drop = 20% compared to post-diluent spirometry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: 1. Subjects not eligible for Methacholine test 2. Subjects who have used treatments that are not allowed before the Methacholine test 3. 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) 4. Administration of another investigational medicinal product within 30 days before the study visit.

Design outcomes

Primary

Measure	Time frame
Main Objective: To show non-inferiority of Buventol Easyhaler to Ventoline Evohaler in treatment of induced bronchoconstriction;Secondary Objective: •To provide further evidence for Bufomix Easyhaler for treatment of acute obstructive events •To obtain inhalation profiles from non-symptomatic subjects, and from subjects during an obstructive event, for both center slot and standard Easyhaler •To develop a statistical prediction model to estimate PIF via Easyhaler using e.g. spirometric PIF (and spirometric inspiratory volume) as predictors.;Primary end point(s): Mean change in FEV1 after dosing when compared to post-diluent FEV1;Timepoint(s) of evaluation of this end point: Immediately after dosing	—

Measure

Time frame

Main Objective: To show non-inferiority of Buventol Easyhaler to Ventoline Evohaler in treatment of induced bronchoconstriction;Secondary Objective: •To provide further evidence for Bufomix Easyhaler for treatment of acute obstructive events •To obtain inhalation profiles from non-symptomatic subjects, and from subjects during an obstructive event, for both center slot and standard Easyhaler •To develop a statistical prediction model to estimate PIF via Easyhaler using e.g. spirometric PIF (and spirometric inspiratory volume) as predictors.;Primary end point(s): Mean change in FEV1 after dosing when compared to post-diluent FEV1;Timepoint(s) of evaluation of this end point: Immediately after dosing

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of subjects who recover to FEV1 > -10% after the first dose of reliever when compared to postdiluent FEV1 after the first dose of reliever. Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1. PIF, acceleration, volume and duration of inhalation will be endpoints for inhalation profiles via Easyhaler inhalers (center slot and standard Easyhaler) Spirometric PIF (and spirometric inspiratory volume);Timepoint(s) of evaluation of this end point: 10 minutes after dosing	—

Measure

Time frame

Secondary end point(s): Proportion of subjects who recover to FEV1 > -10% after the first dose of reliever when compared to postdiluent FEV1 after the first dose of reliever. Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1. PIF, acceleration, volume and duration of inhalation will be endpoints for inhalation profiles via Easyhaler inhalers (center slot and standard Easyhaler) Spirometric PIF (and spirometric inspiratory volume);Timepoint(s) of evaluation of this end point: 10 minutes after dosing

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Countries

Finland

Contacts

Public ContactClinical Trial Information Desk

Orion Corporation

clinicaltrials@orionpharma.com+358104261

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026