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Effectiveness And Safety Of Triamcinolone Tablet In Management of Acute Exacerbations Of Asthma

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048252
Enrollment
100
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma

Interventions

Intervention1: 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,

Sponsors

Dr. S. Balamurugan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Day 0 and 7

Secondary

MeasureTime frame
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 settingsTimepoint: Day 0 and 7

Countries

India

Contacts

Public ContactDr S Balamurugan

Chest and Diabetes Research Institute

dr.s.bala@gmail.com9600002646

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026