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A study for the uses and side effects of corticosteroids and bronchodilator drugs in people with airway problems

A study to evaluate the efficacy and safety profile of inhaled corticosteroid/long acting beta agonist combination among COPD patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021728
Enrollment
80
Registered
2019-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: Budesonide Formoterol Combination: Budesonide Formoterol Combination (BFC) in group I in dose of 200/6 or 400/6 microgm 2 puffs OD over a period of 4 weeks. Route - Inhalational Control

Sponsors

DEPARTMENT OF PHARMACOLOGY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient age more than 40 years. 2. At least 1 inpatient visit with a primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC 3. At least 1 ED visit with a COPD diagnosis (either primary or secondary). 4. Patient not having an exacerbation for one month prior to study entry. 5. Patient on inhalational therapy â?? 2-3 weeks.

Exclusion criteria

Exclusion criteria: 1. Patient diagnosed with asthma or other non-COPD respiratory disorder. 2. Any previous lung volume reduction surgery AND/OR lung transplantation. 3.A requirement for oxygen therapy for at least 12 hours per day. 4. Any exclusionary co-morbid medical condition (cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, or any other condition likely to cause death within 3 years. 5. Current use of oral/injectable corticosteroid therapy. 6. Patients (diagnosed with cancer) who received >= 180 days of oral corticosteroids (OCS) in the 12-month pre-index period. 7. Patients who initiated both study medications on the same date. 8. Immuno-compromised (HIV +ve) patients

Design outcomes

Secondary

MeasureTime frame
To monitor the side effects of both Budesonide/formoterol combination and Fluticasone/salmeterol combination.Timepoint: 4 weeks—

Primary

MeasureTime frame
Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination.Timepoint: Baseline and 4 weeks—

Countries

India

Contacts

Public ContactDR AMRIT PAL KAUR

GOVERNMENT MEDICAL COLLEGE AND RAJINDRA HOSPITAL

vijayksehgal@yahoo.com9872197861

Outcome results

None listed

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