Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease(COPD) II

A randomized, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 48 weeks of once daily treatment of orally inhaled BI 1744 CL (5 Âµg [2 actuations of 2.5 Âµg] and 10 Âµg [2 actuations of 5 Âµg ]) delivered by RespimatÂ® Inhaler, and 48 weeks of twice daily ForadilÂ® (12 Âµg) delivered by the AerolizerÂ® Inhaler, in patients with Chronic Obstructive Pulmonary Disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000147

Enrollment

860

Registered

2009-04-29

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- Chronic Obstructive Pulmonary Disease Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: BI 1744 CL: 5 microgram and 10 microgram once daily, 48 weeks Oral inhalation Control Intervention1: Formoterol: 12 microgram twice daily, 48 weeks Oral inhalation

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1 2. Male or female patients, 40 years of age or older 3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria

Exclusion criteria: 1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN 2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3 3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute) 4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse 5. Patients who have undergone thoracotomy with pulmonary resection 6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. Patients who regularly use daytime oxygen therapy for more than one hour per day. 8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program 9. Pregnant or nursing women 10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

Design outcomes

Primary

Measure	Time frame
There are 3 co-primary endpoints: FEV1 AUC 0 to 3hr response, trough FEV1 response and the Mahler TDI (focal score: combined with 1222.13 trial) 24 WeeksTimepoint: 24 weeks	—

Secondary

Measure	Time frame
FEV1 AUC response after 2, 6, 12 and 48 weeks FEV1 trough after 2, 6, 12, 18, 24, 32, 40 and 48 weeks FEV1 peak SGRQ after 12 and 48 weeks 48 WeeksTimepoint: 2, 6, 12, 18, 24, 32, 40 and 48 weeks	—

Countries

India, Thailand

Contacts

Public ContactSuchela Srivatsa

IQVIA RDS (India) Private Limited

shoibal.mukherjee@quintiles.com91-7838652395

Outcome results

None listed

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