Asthma (Diagnosis)
Conditions
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.
Interventions
DRUGMDI 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.
DRUGDPI 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.
Sponsors
Bugra Kerget
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV₁ (%) from Baseline to 1 Month | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed