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

NCT05428956 | Completed DMC

• 1 other identifier: INT/IEC/2016/976
• Study Type: interventional
• Target: 897
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• percentage change in FEV1

  48 hours

• Change in FVC in mL

  48 hours

• percentage change in FVC

  48 hours

• percentage change in PEFR

  48 hours

• Change in PEFR, in mL

  48 hours

Study Arms (2)

Single breath technique

ACTIVE COMPARATOR

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; Procedure: Tidal inhalation technique

Tidal breath technique

EXPERIMENTAL

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; Procedure: Tidal inhalation technique

Interventions

Single Inhalation technique PROCEDURE

Single maximal inhalation with breath hold technique

Single breath technique; Tidal breath technique

Tidal inhalation technique PROCEDURE

5 tidal breaths technique

Single breath technique; Tidal breath technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Bronchoscopy suite, PGIMER

Chandigarh, 160012, India

Location

Chest clinic

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will perform the spirometry after use of short acting bronchodilator with a spacer using both single breath and 5-tidal breath on two consecutive days. The investigator, care provider and outcome assessor will be masked for allocation. The spirometry will be performed by a respiratory technician not involved in patient care
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All the patients will receive inhaled salbutamol using two techniques during lung function testing on two successive days. Patient will be randomized 1:1 to receive inhaled salbutamol by performing either a single breath holding maneuver or by five tidal breaths on the first day of evaluation. Each patient will undergo spirometry using the other alternative procedure on the next day. The randomization sequence will be computer generated. The sequence generated will be kept in a sealed opaque envelope and will be opened at the time of procedure

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 23, 2022
• Study Start: June 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

IN (2)