Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler

NCT07372573 | Not Yet Recruiting DMC

• 1 other identifier: #PMDIDPI#
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis)

Keywords

Asthma; Pressrized Meter Dose inhaler; Dry powder Inhaler; long acting beta Agonist; inhaled corticosteroid

Outcome Measures

Primary Outcomes (1)

• Asthma Control Questionnaire (ACQ) score

  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

Study Arms (2)

Group A

EXPERIMENTAL

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)

Group B

ACTIVE COMPARATOR

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

Interventions

Pressurized Metered Dose Inhaler (pMDI) DEVICE

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.

Group A

Dry Powder Inhaler DEVICE

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.

Group B

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14 to 60 years
• Both genders
• All patients with symptoms of uncontrolled asthma

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

Study Sites (1)

Services Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Asthma; Disease

Interventions

Dry Powder Inhalers

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

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Central Study Contacts

Syeda Xunaira Qamar Dr, MBBS

CONTACT

+92 302 8685212; Syedaxunairaqamar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)