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

NCT07232264 | Completed

• 1 other identifier: B.30.2ATA.0.01.00/600
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma (Diagnosis)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and 1 month after treatment initiation

Study Arms (2)

MDI Group

EXPERIMENTAL

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.

Drug: MDI Inhaler Therapy

DPI Group

EXPERIMENTAL

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.

Drug: DPI Inhaler Therapy

Interventions

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.

MDI Group

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.

DPI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bugra Kerget: lead

Study Sites (1)

Ataturk University

Erzurum, 25200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma; Disease

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pulmonary Medicine, Atatürk University Faculty of Medicine

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: March 1, 2025
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TU (1)