| CTRI Number |
CTRI/2022/12/048252 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness And Safety Of Triamcinolone Tablet In Management of Acute Exacerbations Of Asthma |
|
Scientific Title of Study
|
A Prospective, Single-center, Single-Arm, Open-Label, Study To Assess The Effectiveness And Safety Of Triamcinolone Oral Tablet In Management of Acute Exacerbations Of Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Balamurugan |
| Designation |
Consultant Pulmonologist |
| Affiliation |
Chest and Diabetes Research Institute |
| Address |
Department of Respiratory medicine
Chest and Diabetes Research Institute
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu. India.
Chennai
TAMIL NADU
600087
India |
| Phone |
9600002646 |
| Fax |
|
| Email |
dr.s.bala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Balamurugan |
| Designation |
Consultant Pulmonologist |
| Affiliation |
Chest and Diabetes Research Institute |
| Address |
Department of Respiratory medicine
Chest and Diabetes Research Institute
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu. India.
Chennai
TAMIL NADU
600087
India |
| Phone |
9600002646 |
| Fax |
|
| Email |
dr.s.bala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Balamurugan |
| Designation |
Consultant Pulmonologist |
| Affiliation |
Chest and Diabetes Research Institute |
| Address |
Department of Respiratory medicine
Chest and Diabetes Research Institute
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu. India.
Chennai
TAMIL NADU
600087
India |
| Phone |
9600002646 |
| Fax |
|
| Email |
dr.s.bala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051, India. |
|
|
Primary Sponsor
|
| Name |
Dr. S. Balamurugan |
| Address |
Department of Respiratory medicine
Chest and Diabetes Research Institute
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu. India. |
| Type of Sponsor |
Other [Investigator Initiated Survey] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Balamurugan |
Chest and Diabetes Research Institute |
2, First Cross Street, Janaki Nagar Extension, Valasaravakkam, Chennai 600087, Tamil Nadu. India
Chennai
TAMIL NADU |
9600002646
dr.s.bala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RIPON Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Triamcinolone 4mg tablets |
Patients will be prescribed triamcinolone tablets at a dose of 4mg to 16mg per day, as per the discretion of the investigator, for a period of Seven (7)-days, to be taken with water preferably after meals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of ≥18-≤65 years.
2. Previously diagnosed case of bronchial asthma for at least 6 months, before the screening date.
3. A primary diagnosis of mild to moderate acute exacerbation of asthma (with symptoms of shortness of breath, frequent or recurrent cough, wheezing, mucus production, and/ or tightness in the chest) on presentation.
4. Patients on a stable dose of asthma medications for at least 3 months, before the screening date.
5. No other acute pathology complicating the present condition i.e. cardiac, metabolic, or any other respiratory causes.
6. Patients willing to participate in the study and sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
A patient will be excluded from the study if they meet any of the following criteria:
1. Patients with a smoking history of more than 10 packs a year.
2. Patients with a history of Alcohol consumption.
3. Patients treated with oral or parenteral steroids for >5 days in the past 30-days.
4. Patients treated with theophylline ≤5-days, before the screening date.
5. Patients having uncontrolled diabetes or uncontrolled hypertension.
6. Patients having active tuberculosis.
7. Patients on regular Rifampicin, Phenytoin, or Phenobarbitone.
8. Pregnant and nursing women.
9. Women with childbearing potential who are not practicing a reliable method of birth control.
10. Patients with a known history of hypersensitivity to triamcinolone.
11. Suspected inability or unwillingness to comply with study procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of triamcinolone oral tablets adjunct to standard of care (SOC) treatment in managing mild to moderate acute exacerbations of asthma symptoms, assessed by asthma control questionnaire-6 (ACQ-6) in routine outpatient clinical settings. |
Day 0 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of triamcinolone oral tablets adjunct to SOC treatment in improving lung function in patients with mild to moderate acute exacerbations of asthma, in routine outpatient clinical settings |
Day 0 and 7 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2022 |
| Date of Study Completion (India) |
30/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, single-center, single-arm, open-label, study designed to assess the effectiveness and safety of triamcinolone oral tablets adjunct to SOC treatment in the management of patients with mild to moderate acute exacerbations of asthma. This study plans to enroll 100 patients with mild to moderate acute exacerbation of asthma. The patients will be followed up for 7-days after enrollment into the study. The patients will be prescribed triamcinolone tablets at a dose of 4mg to 16mg per day, as per the discretion of the investigator, for a period of Seven (7)-days, to be taken with water preferably after meals, adjunct to SOC treatment, which will include inhaled corticosteroids (ICS) with or without long-acting beta2-agonist (LABA). The selection of patients for the study will be totally at the discretion of the investigator. All patients diagnosed with mild to moderate acute exacerbation of asthma, meeting inclusion & exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this study. At the baseline (Visit 1 [Day 0]), informed consent will be taken, before assessing the patient’s eligibility and entry into the study. Patients fulfilling all of the inclusion and violating none of the exclusion criteria will be enrolled in the study. Post entry of a patient into the study demographic details- age, gender, and socioeconomic status, will also be captured and clinical examination, which will include a record of vitals (including BP, HR, and RR), physical and systemic examination, will be done. Detailed medical history (including duration of disease, present treatment regime, co-existing condition, etc.) will be taken. At baseline (Visit 1 [Day 0]), patients with acute exacerbations of asthma will be evaluated for adequacy of asthma control by ACQ-6 and assessment of lung functions by FEV1 and PEFR. The patient will also be prescribed oral triamcinolone 4mg tablets at a dose of 4mg to 16 mg per day, as per the discretion of the investigator, for the period of Seven (7)-days at the baseline, along with SOC treatment (ICS with or without LABA). Progress made by the patient will be reviewed on Day Seven (7) (end of study visit). |