Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler

January 19, 2026 updated by: Laiba Qamar, University of Health Sciences Lahore

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Services Hospital Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 14 to 60 years

Both genders

All patients with symptoms of uncontrolled asthma

Exclusion Criteria:

Patients with coexistent fungal sensitization (confirmed with peripheral eosinophil count and serum IgE)

Patients with coexistent Allergic Bronchopulmonary Aspergillosis (ABPA) (confirmed with HRCT and serum IgE)

Patients with coexistent COPD (confirmed on spirometry)

Patients with Hypersensitivity Pneumonitis

Patients with coexistent Interstitial Lung Disease (ILD) (confirmed on spirometry)

Patients with coexistent cardiac asthma secondary to heart failure (diagnosed on echocardiography)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients in this arm will receive a fixed-dose combination of inhaled corticosteroid and long-acting beta agonist (budesonide/formoterol) via a pressurized metered dose inhaler. The prescribed dose will be 200/6 µg per puff, two puffs twice daily, delivering a total daily dose of 800/24 µg. This arm evaluates the effectiveness of aerosol-based drug delivery requiring hand-breath coordination.
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.
Active Comparator: Group B

Patients in this arm will receive the same fixed-dose combination of budesonide/formoterol via a dry powder inhaler at a dose of 400/12 µg per puff, one puff twice daily, achieving the same total daily dose of 800/24 µg. This arm assesses the effectiveness of breath-actuated powder-based drug delivery.

Both arms use equivalent drug molecules and doses, with the inhaler device being the only variable, allowing direct comparison of device-related effectiveness in uncontrolled asthma.

If you want, I can also write this in tabular form or CPSP RTMC-preferred wording.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Questionnaire (ACQ) score
Time Frame: 8 weeks
The primary outcome of this study is improvement in asthma control, assessed by the change in Asthma Control Questionnaire (ACQ) score from baseline to 8 weeks after intervention. Effectiveness will be determined by a reduction in ACQ score compared to the baseline value, reflecting better symptom control with the assigned inhaler device.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #PMDIDPI#

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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