Clinical trial NCT06657066: EFFECTIVENESS of PROBIOTICS in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA
Official title: EFFECTIVENESS of PROBIOTIC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in ADULTS with MODERATE to SEVERE PERSISTENT ASTHMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma Patients
Keywords: Asthma
Probiotics
Standard Therapy
adjuvant
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomize Clinical Trial
Primary purpose: TREATMENT

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

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.

Detailed description: 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

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

Exclusion Criteria

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

Eligibility criteria: Inclusion Criteria

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

Exclusion Criteria

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

Primary outcomes:
measure: Frequencies of exacerbation
timeFrame: 3 months
Secondary outcomes:
measure: Improvment of FEV1 and FEV1/FVC ratio
timeFrame: 3 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University, Neelagumbad, Anarkali, Lahore, Pakistan. Postal Code: 54000 Telephone: +92 (42) 99211145-54
state: Punjab
Study officials:
affiliation: King Edward Medical University Lahore
name: Dr. Binayak Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: