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Study for the comparison of usefulness and quality of life of patients with airway disease after taking corticosteroid and bronchodilator drug combination

A study to evaluate the real world effectiveness of Inhaled corticosteroid/Long acting beta agonist combination and assessment of Health related quality of life among COPD patients on this therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028365
Enrollment
80
Registered
2020-10-13
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: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: Budesonide Formoterol combination: Budesonide Formoterol combination given in group I in dose of 200/6 or 400/6 microgram 2 puffs OD for a period of 4 weeks. Route - Inhalational Contro

Sponsors

Department of Pharmacology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients of age 40 years or more. 2. Patient with at least 1 Inpatient Department visit with primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC 3. Patient with at least 1 Emergency Department visit with COPD diagnosis. 4. Patient not having an exacerbation for one month prior to study entry. 5. Patient on inhalational therapy for 2-3 weeks.

Exclusion criteria

Exclusion criteria: 1. Patient diagnosed with asthma or other non-COPD respiratory disorder. 2. Patient with history of any previous lung volume reduction surgery and/or lung transplantation. 3. Patient who requires 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. Immuno-compromised (HIV +ve) patients 8. Patients who are not willing to give written informed consent.

Design outcomes

Primary

MeasureTime frame
Comparison in exacerbation rate and SGRQ score in patients of COPD on Budesonide/Formoterol combination versus Fluticasone/Salmeterol combination.Timepoint: 2 week and 4 weeks—

Secondary

MeasureTime frame
To manage the side effects of both Budesonide/Formoterol combination and Fluticasone/Salmeterol combination in COPD patients.Timepoint: 2 week and 4 weeks—

Countries

India

Contacts

Public ContactDr Amrit Pal Kaur

Government Medical College and Rajindra Hospital, Patiala

vijayksehgal@yahoo.com9872197861

Outcome results

None listed

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