Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After SABA Administration in Bronchial Asthma

A Randomized Controlled Trial of Two Inhalation Methods Using a Pressurized Metered Dose Inhaler With Valved Holding Chamber to Assess Improvement in Lung Function After Short-acting Beta-2 Agonist Administration in Treatment-naïve Adult Patients With Bronchial Asthma

Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough. The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.

In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.

The authors hypothesized that both the techniques would improve FEV1 similarly.

Study Overview

• Status: Completed
• Conditions: Bronchial Asthma
• Intervention / Treatment: Procedure: Single Inhalation technique; Procedure: Tidal inhalation technique

Detailed Description

Bronchial asthma is a chronic inflammatory disorder characterized by recurrent reversible episodes of breathlessness, wheezing, chest tightness and/ or cough.1 The prevalence of asthma in India is about 2%, and asthma is responsible for significant morbidity. A diagnosis of asthma is made in the presence of clinical symptoms with or without reversibility on spirometry assessment.1 Treatment comprises of inhaled medications that are used either as controller medication or a reliever medications.1 PEF measurements are known to be affected by the technique and the equipment by which it is measured, and thus proper instructions and training are essential for the patient.1 PEF measurements have been used in the past as a surrogate to FEV1 measurements, but the correlation between them is poor and hence they should not be used interchangeably. If PEF falls below 80% of personal best, it is suggestive of inadequate disease control.1 Inhaled medications are delivered through various device either as dry powder forms or in a pressurized meter dose inhaler (pMDI). However, the drug delivery is variable and a pMDI delivers only 10-20% of the nominal dose per actuation or puff, even when used correctly.2,3 Use of spacer improves the drug delivery and the recent Indian guidelines recommends use of pMDI with a spacer as an effective drug delivery system. Tidal breathing with a pMDI with spacer is as effective as the single breath method as per the British/Scottish Intercollegiate Guidelines Network (SIGN) recommendations.4 Breath-holding is usually recommended after the aerosol inhalation, but there is limited information on the clinical importance of breath-holding in adult asthmatic patients. In a recent study involving asthmatic children, single maximal inhalation with breath hold was not found to be superior to tidal breathing for improvement in peak expiratory flow rates.5 Information on comparative efficacy of either method is limited in adult asthmatics. The authors hypothesized that both the techniques would improve FEV1 similarly. Thus, the objective of the present study is to assess improvement in lung function (FEV1) after short-acting beta-2 agonist administration in treatment-naïve adult patients with bronchial asthma with a single maximal inhalation with breath-hold versus 5 tidal breaths during inhalation using a valved holding chamber.

• Study Type: Interventional
• Enrollment (Actual): 897
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Bronchoscopy suite, PGIMER
  • Chandigarh, India, 160012
    • Chest clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(a) Patients with a physician diagnosis of bronchial asthma undergoing spirometry (b) ability to provide informed consent to participate in the study

Exclusion Criteria:

(a) Patients having active pulmonary tuberculosis; (b) pregnancy; (c) patients already on inhaled or oral bronchodilators or corticosteroids as part of asthma treatment; and, (d) failure to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single breath technique; The technique of single maximal inhalation will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale slowly and maximally and hold the breath for at least 5 seconds. After the breath holding maneuver the patient will be asked to exhale. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval. The duration of the breath hold will be measured by a stop watch.	Procedure: Single Inhalation technique; Single maximal inhalation with breath hold technique; Procedure: Tidal inhalation technique; 5 tidal breaths technique
Experimental: Tidal breath technique; The technique of 5 tidal breaths will be demonstrated to all the patients by a technician. In brief the patient will be asked to inhale 5 tidal breaths after administrating salbutamol in the spacer. After each breath patient will be asked to breathe out in the spacer. The spacer has a one way-valve and does not allow the exhaled air to enter in to the chamber, thus preventing rebreathing and dilution of the inhaled medicine. Salbutamol (100µg) be administered in a dose of 2 puffs, each after a one minute interval	Procedure: Single Inhalation technique; Single maximal inhalation with breath hold technique; Procedure: Tidal inhalation technique; 5 tidal breaths technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 (ml)	absolute change in FEV1 after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage change in FEV1	percentage change in FEV1 after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique	48 hours
Change in FVC in mL	absolute change in FVC, and PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique	48 hours
percentage change in FVC	percentage change in FVC after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique	48 hours
percentage change in PEFR	percentage change in PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique	48 hours
Change in PEFR, in mL	absolute change in PEFR after inhaled salbutamol administered with a valved spacer using single maximal inhalation with breath hold and 5-tidal breaths technique	48 hours

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: INT/IEC/2016/976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will share IPD on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No