Efficacy of Triple versus Dual Therapy in COPD Using Surfactant Protein-D as a Biomarker

Comparing the Efficacy of Triple Therapy and Dual Therapy in COPD Patients using Surfactant Protein-D as a Biomarker : A Randomized Controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080369

Enrollment

224

Registered

2025-02-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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 Glycopyrrolate Formoterol: Dose and Composition: Budesonide 160 mcg Glycopyrrolate 9 mcg Formoterol 4.8 mcg. Mode of Administration: Administered via a single metered-dose

Eligibility

Inclusion criteria

Inclusion criteria: Post bronchodilator FEV1/FVC ration less than 0.70 History of at least 1 moderate or severe exacerbation in the past 12 months Eosinophil count more than 100 cells per microliter CAT score more than 10 or mMRC dyspnea score more than or equal to 2

Exclusion criteria

Exclusion criteria: Diagnosis of asthma or other significant respiratory diseases (e.g., pulmonary fibrosis, lung cancer). History of severe cardiovascular diseases (e.g., myocardial infarction, unstable angina, heart failure). Patients with severe cognitive or psychiatric disorders that may impair study participation. History of hypersensitivity to any of the study medications. Active infections requiring antibiotics or systemic steroids at the time of enrollment. Women who are pregnant, and breastfeeding.

Design outcomes

Primary

Measure	Time frame
To assess changes in forced expiratory volume in 1 second (FEV1) from baseline, and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation. Timepoint: To assess changes in forced expiratory volume in 1 second (FEV1) from baseline,12 and 24 weeks and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.	—

Measure

Time frame

To assess changes in forced expiratory volume in 1 second (FEV1) from baseline, and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation. Timepoint: To assess changes in forced expiratory volume in 1 second (FEV1) from baseline,12 and 24 weeks and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.

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Secondary

Measure	Time frame
To assess the impact of BGF triple therapy compared to dual therapy on symptom relief, using the COPD Assessment Test (CAT) & Modified Medical Research Council (mMRC) Dyspnea Scale. To evaluate changes in quality of life (QoL) between treatment groups, measured by the St. George s Respiratory Questionnaire (SGRQ). To evaluate the effect of BGF triple therapy versus dual therapy on exacerbation frequency, defined as moderate or severe exacerbations requiring treatment or hospitalization. To investigate changes in Surfactant Protein D (SP-D) levels in response to treatment & their association with clinical outcomes such as lung function, symptoms, & exacerbation rates. Timepoint: baseline 12 weeks 24 weeks	—

Measure

Time frame

To assess the impact of BGF triple therapy compared to dual therapy on symptom relief, using the COPD Assessment Test (CAT) & Modified Medical Research Council (mMRC) Dyspnea Scale. To evaluate changes in quality of life (QoL) between treatment groups, measured by the St. George s Respiratory Questionnaire (SGRQ). To evaluate the effect of BGF triple therapy versus dual therapy on exacerbation frequency, defined as moderate or severe exacerbations requiring treatment or hospitalization. To investigate changes in Surfactant Protein D (SP-D) levels in response to treatment & their association with clinical outcomes such as lung function, symptoms, & exacerbation rates. Timepoint: baseline 12 weeks 24 weeks

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Countries

India

Contacts

Public ContactDr T M Vijayakumar

SRM college of Pharmacy SRMIST

nalinijayanthi59@gmail.com9444226783

Outcome results

None listed

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