A Phase 2/3 interventional study of Beclomethasone 200mcg, salbutamol 100mcg , Beclomethasone 200 mcg/Formoterol 6 mcg, 250 mg of lyophilized saccharomyces boulardii and Control (Standard treatment) in Asthma Patients, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by King Edward Medical University · Phase 2/3, Interventional, and Treatment
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
Design of Study This was a Randomized controlled trial
Follow up protocol The patient was evaluated at the beginning of the study, and then again at one and three months following enrolment for a follow-up evaluation of the main and secondary outcomes.
Primary outcome To assess the frequency of exacerbations within 3 months.
Secondary outcome:
To observe improvement in
Sampling technique - Simple random sampling Sample selection Inclusion Criteria
Exclusion Criteria
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 74 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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
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)
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
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
Frequencies of exacerbation
Assessment of the frequency of exacerbations within 3 months will be observed among the intervention \& control grouo
Time frame: 3 months
Improvment of FEV1 and FEV1/FVC ratio
To observe improvement in 1. FEV1 and the FEV1/FVC ratio. Improvement in one step and more than 12% Improvement in FEV1 from baseline. Improvement in asthma control test.
Time frame: 3 months
Plan to share: No — Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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King Edward Medical University