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OpenTrials
Completed

NCT Number: NCT07232264

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDI Inhaler Therapy

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 Inhaler Therapy

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.

Primary outcomes

  1. Change in FEV₁ (%) from Baseline to 1 Month

    Time frame: Baseline and 1 month after treatment initiation

    The primary outcome is the change in forced expiratory volume in one second (FEV₁) expressed as percent of predicted from baseline to one month after initiation of inhaler therapy. Pulmonary function tests were performed according to ATS/ERS 2019 guidelines using the same spirometry device for all participants.

Sponsors and collaborators

Lead sponsor

Bugra Kerget

Other

Registry information

Official study title

Respiratory and Peripheral Muscle Strength as Predictors of Inhaler Treatment Response in Asthma: A Randomized Comparison of Dry Powder and Metered Dose Inhalers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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