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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
5. HYPOTHESIS Probiotics as an adjuvant to standard therapy is more effective as compared to the standard therapy alone in managing moderate to severe persistent bronchial asthma.
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
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. Sample Size - The calculated sample size is 74 individuals (37 in each category i.e Intervention & Control arm)
Sampling technique - Simple random sampling Sample selection Inclusion Criteria
Exclusion Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of exacerbation | Assessment of the frequency of exacerbations within 3 months will be observed among the intervention & control grouo | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Binayak Singh, MD | King Edward Medical University Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Edward Medical University, Neelagumbad, Anarkali, Lahore, Pakistan. Postal Code: 54000 Telephone: +92 (42) 99211145-54 | Lahore | Punjab Province | 54000 | Pakistan |
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| Label | URL |
|---|---|
| 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 | View source |
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Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
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Randomize Clinical Trial
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Double Blind
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| 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. |
|
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000420 | Albuterol |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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