Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Comparison of DPI and MDI Devices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-09-24

Brief Summary

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Asthma is a chronic respiratory disease characterized by variable airway obstruction. Inhaled therapies are the cornerstone of asthma management, and selecting the appropriate inhaler device is essential for effective treatment. Among available devices, metered dose inhalers (MDIs) and dry powder inhalers (DPIs) are commonly used; however, their effectiveness depends not only on the medication but also on the patient's physiological capacity and inhalation technique.

This prospective randomized study aimed to evaluate the factors influencing inhaler treatment response in newly diagnosed asthma patients. A total of 80 patients with at least a high school education, who demonstrated perfect inhaler technique and adherence, were randomly assigned to MDI or DPI groups (n = 40 each). Baseline and one-month follow-up assessments included pulmonary function tests (PFTs), inspiratory and expiratory muscle strength measurements (MIP, MEP), Asthma Control Test (ACT), and handgrip strength (HGS).

The study investigated how respiratory and peripheral muscle strength, inspiratory capacity, coordination skills, and clinical status affect treatment outcomes with MDI and DPI. Findings from this research may help guide inhaler selection based on patient-specific physiological characteristics to optimize treatment effectiveness.

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Detailed Description

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Conditions

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Asthma (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MDI Group

Participants receive inhaled therapy using metered-dose inhalers (MDIs) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, 2 puffs twice daily for one month.

Group Type EXPERIMENTAL

MDI Inhaler Therapy

Intervention Type DRUG

Patients in the MDI group received Foster® metered-dose inhaler (MDI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, administered as two puffs twice daily for one month.

DPI Group

Participants receive inhaled therapy using dry powder inhalers (DPIs) (Foster® Nexthaler) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, 2 inhalations twice daily for one month.

Group Type EXPERIMENTAL

DPI Inhaler Therapy

Intervention Type DRUG

Patients in the DPI group received Foster® Nexthaler dry powder inhaler (DPI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, administered as two inhalations twice daily for one month.

Interventions

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MDI Inhaler Therapy

Patients in the MDI group received Foster® metered-dose inhaler (MDI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per actuation, administered as two puffs twice daily for one month.

Intervention Type DRUG

DPI Inhaler Therapy

Patients in the DPI group received Foster® Nexthaler dry powder inhaler (DPI) containing beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg per inhalation, administered as two inhalations twice daily for one month.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Adults aged ≥ 18 years Newly diagnosed asthma according to GINA guidelines Education level of at least high school Ability to use inhaler devices correctly after standardized training Provided written informed consent to participate

Exclusion Criteria

Presence of other chronic lung diseases (e.g., COPD, interstitial lung disease) Acute asthma exacerbation at the time of enrollment Severe neurological or cognitive impairment affecting inhaler use

Pregnancy or breastfeeding

Refusal or inability to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No