The Effect of Empagliflozin on Spirometric Indices in Patients With Chronic Obstructive Pulmonary Disease

Investigating The Effect of Empagliflozin on Spirometric Indices in Patients With Chronic Obstructive Pulmonary Disease : A Randomized Clinical Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251127068134N1

Enrollment

Registered

2025-12-17

Start date

2026-01-20

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Chronic Obstructive Pulmonary Disease. Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention 1: Intervention group: Standard treatment (Flosalmax inhaler, two puffs every 12 hours

manufactured by Jaber Pharmaceutical Company) plus Empagliflozin 10 mg tablet (manufactured by Abidi Pharmaceutical Company), once daily for 12 weeks. Intervention 2: Control group: Standard treatment

manufactured by Jaber Pharmaceutical Company).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Written informed consent to participate in the study Glomerular filtration rate above 30 ml/min

Exclusion criteria

Exclusion criteria: Presence of active genital infection Diabetes mellitusUnderlying heart failure, Underlying renal failure with serum creatinine equal to or greater than 3 mg/dL Pregnancy Any allergic reaction, angioedema, acute kidney injury, ketoacidosis, urinary tract infection caused by empagliflozin

Design outcomes

Primary

Measure	Time frame
Mean spirometry parameters (FEV1 volume, FVC, FEV1/FVC ratio). Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Spirometry device.;Frequency of activity classes in COPD patients. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Questionnaire.;Mean systolic blood pressure. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Mercury sphygmomanometer.;Mean blood oxygen saturation. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Pulse oximetry device.	—

Measure

Time frame

Mean spirometry parameters (FEV1 volume, FVC, FEV1/FVC ratio). Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Spirometry device.;Frequency of activity classes in COPD patients. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Questionnaire.;Mean systolic blood pressure. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Mercury sphygmomanometer.;Mean blood oxygen saturation. Timepoint: Before the intervention and after taking empagliflozin. Method of measurement: Pulse oximetry device.

—

Secondary

Measure	Time frame
Number of hospitalizations. Timepoint: After administration of empagliflozin. Method of measurement: Checklist.;Frequency of COPD exacerbations. Timepoint: After administration of empagliflozin. Method of measurement: Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Habibi

Shahre-kord University of Medical Sciences

habibi.z@skums.ac.ir+98 38 3222 0016

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026