NCT07372573

Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler

Effectivenes of Pressurized Meter Dose Inhaler (PMDI) Versus Dry Powder Inhaler (DPI) in Delivering Inhaled Corticosteroid and Long Acting Beta Agonist Among Patients With Uncontrolled Asthma in a Tertiary Care Hospital.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University of Health Sciences Lahore · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study compares two commonly used inhalation devices in asthma management. It focuses on evaluating how effectively PMDIs and DPIs deliver the same combination of inhaled corticosteroids and long-acting beta agonists in patients whose asthma remains poorly controlled despite treatment. The study is conducted in a tertiary care hospital setting, emphasizing real-world clinical practice and aiming to determine whether device choice influences asthma control outcomes.

Detailed description

Asthma is a common chronic respiratory disease, and despite advances in therapy, a significant proportion of patients remain poorly controlled. Inhaled corticosteroids (ICS) combined with long-acting beta agonists (LABA) are the cornerstone of asthma management; however, the effectiveness of treatment is highly dependent on the inhalation device used. Pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) are the most widely used devices, yet their relative effectiveness in real-world clinical practice remains debated, particularly in resource-limited settings. This randomized controlled trial aims to compare the effectiveness of pMDI versus DPI in delivering equivalent doses of ICS/LABA among patients with uncontrolled asthma attending the Pulmonology Outpatient Department of Services Hospital Lahore. A total of 210 patients aged 14-60 years with uncontrolled asthma, defined by an Asthma Control Questionnaire (ACQ) score ≥3 despite baseline therapy, will be enrolled using non-probability consecutive sampling and randomized into two groups. Both groups will receive an equivalent total daily dose of budesonide/formoterol (800/24 µg), administered either via pMDI or DPI. Patients will be followed for eight weeks with assessments at baseline, four weeks, and eight weeks. The primary outcome will be improvement in asthma control measured by reduction in ACQ score, while secondary outcomes include frequency of asthma exacerbations. Data will be analyzed using SPSS version 25, with appropriate statistical tests applied to compare outcomes between groups. The findings of this study are expected to clarify whether inhaler device choice significantly influences asthma control. This will help distinguish true treatment-resistant asthma from poor control due to device-related factors and guide clinicians in selecting the most effective inhalation device for improved patient outcomes.

Conditions

• Asthma (Diagnosis)

Interventions

Type	Name	Description
DEVICE	Pressurized Metered Dose Inhaler (pMDI)	Participants allocated to this group will be treated with a combination of inhaled corticosteroid and long-acting beta agonist in the form of budesonide/formoterol 200/6 micrograms per actuation delivered via a pressurized metered dose inhaler. Patients will be instructed to take two puffs twice daily, resulting in a total daily dose of 800 micrograms of budesonide and 24 micrograms of formoterol. This intervention evaluates medication delivery through an aerosolized spray that requires proper coordination between actuation and inhalation.
DEVICE	Dry Powder Inhaler	articipants in this group will receive the same combination therapy of budesonide/formoterol 400/12 micrograms per inhalation administered through a dry powder inhaler. The prescribed regimen will be one inhalation twice daily, providing an equivalent total daily dose of 800 micrograms of budesonide and 24 micrograms of formoterol. This intervention assesses drug delivery via a breath-activated powder formulation, where adequate inspiratory effort is required for optimal drug deposition.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Pakistan