EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA

NCT06657066 | Completed Phase 2 DMC

• 1 other identifier: 6952/REG/KEMU/22MD200023
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the effectiveness of probiotic as an adjuvant to standard therapy versus standard therapy alone in adult with moderate to severe persistent asthma in terms of

1. 1.Frequency of asthma exacerbations in terms of number of asthma attacks and severity of each episode.
2. 2.Improvement in pulmonary function tests as recorded by an increase in FEV1 and FEV1/FVC ratio.

Conditions

Asthma Patients

Keywords

Asthma; Probiotics; Standard Therapy; adjuvant

Outcome Measures

Primary Outcomes (1)

• Frequencies of exacerbation

  Assessment of the frequency of exacerbations within 3 months will be observed among the intervention \& control grouo

  3 months

Secondary Outcomes (1)

• Improvment of FEV1 and FEV1/FVC ratio

  3 months

Study Arms (2)

Intervention arm - Group A

EXPERIMENTAL

Standar Therapy- Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram. Along with Probiotics i.e Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii

Drug: Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii

Control arm- Group B

PLACEBO COMPARATOR

Standard therapy only: Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram

Drug: Control (Standard treatment)

Interventions

Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii DRUG

Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram plus Saccharomyces boulardii, available in sachet from employed in this research containing 250 mg of lyophilized saccharomyces boulardii. It was given daily for three months

Also known as: Group A

Intervention arm - Group A

Control (Standard treatment) DRUG

The control arm will receive only standard treatment for asthma i.e Daily low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram as needed Short acting beta 2 agonist (SABA)/salbutamol 100mcg ,OR as needed low dose inhaled corticosteroid (ICS)/ Beclomethasone 200 microgram -Long acting Beta2 Agonist (LABA)/Formeterol 6 microgram.

Also known as: Group B

Control arm- Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient of both genders between the ages of 18 and 80 years.
• Diagnosed cases of moderate to severe persistent asthma, as determined by ACT Score and FEV1/FVC ratio as per operational definition.

You may not qualify if:

• Patients with Mild asthma.
• Pregnant females.
• Patients who have taken fiber supplements or probiotics during the last four weeks.
• Other pulmonary disorders, such as Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis (ABPA), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer.
• Asthma and chronic obstructive pulmonary disease overlap syndrome (ACOS).

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University, Neelagumbad, Anarkali, Lahore, Pakistan. Postal Code: 54000 Telephone: +92 (42) 99211145-54

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

• Clinical and molecular phenotypes of asthma are complex. The main phenotypes of adult asthma are characterized by eosinophil and/or neutrophil cell dominant airway inflammation that represent distinct clinical features. Upper and lower airways constitute

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Albuterol; Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Dr. Binayak Singh, MD

  King Edward Medical University Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD (Postgraduate Trainee)

Model Details: Randomize Clinical Trial

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 24, 2024
• Study Start: December 6, 2021
• Primary Completion: April 24, 2022
• Study Completion: August 8, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)