To compare the efficacy and safety of IN-ALR-01 versus IN-ALR-01 with Tiotropium and IN-ALR-01 with Salmeterol in patients with moderate to severe COPD

An Open label, Phase III, Randomized, Parallel Group, Prospective, Multicentre Clinical Trial for Evaluation of Efficacy and Safety of IN-ALR-01 versus IN-ALR- 01 with Tiotropium or Salmeterol in Patients with Moderate to Severe COPD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/12/003177

Enrollment

300

Registered

2012-12-04

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: null- Moderate to Severe COPD

Interventions

Intervention1: Tablet Roflumilast 500Î¼g : One tablet to be taken once daily route of administration: oral administration Duration of therapy: 24 weeks Control Intervention1: Combination of Tablet Ro

Eligibility

Inclusion criteria

Inclusion criteria: • Age > than 40 yrs • Smoker with a smoking history of at least ten pack-years • Patient with moderate to severe COPD • Stable clinical disease status with no change in COPD treatment during the 4 weeks before screening period • Female patients of childbearing potential- if they are willing to use a medically valid and effective contraception throughout the study period • Patients are willing to provide written informed consent

Exclusion criteria

Exclusion criteria: • Patients with asthma or other relevant active lung diseases (e.g., lung cancer, tuberculosis, bronchiectasis etc.) • Patients on long-term oxygen treatment • Recent exacerbation of COPD that required a course of systemic corticosteroids, emergency room treatment, or hospital admission (within 4 weeks before screening period) • Serious cardiovascular diseases (uncontrolled hypertension, angina pectoris, myocardial infarction, etc.) • History known alpha-1-antitrypsin deficiency • Patients with Hepatic insufficiency (SGOT/SGPT _ 2.0 x ULN) or Renal insufficiency (serum creatinine _ 1.5 x ULN) • Clinically significant abnormalities on physical examination or laboratory tests • History of any neuropsychiatric illness or suicidal thoughts & tendency • Pregnant, lactating / nursing women • Patients having participated in any type of clinical study within in the last one month of the screening date

Design outcomes

Primary

Measure	Time frame
Change in mean prebronchodilator FEV1 from baseline to each postrandomisation visit between treatment arms.Timepoint: Change in mean prebronchodilator FEV1 from baseline to each postrandomisation visit between treatment arms.	—

Secondary

Measure	Time frame
â?¢ Change in mean postbronchodilator FEV1 and FVC from baseline to each postrandomization visit. â?¢ Rate of COPD exacerbations between treatment arms â?¢ Use of rescue medicationsTimepoint: 24 WEEKS	—

Countries

India

Contacts

Public ContactDr Dimple Shah

Intas Pharmaceuticals Ltd

kishore_sonkusare@intaspharma.com66117406

Outcome results

None listed

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