Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 3

Conditions: COPD

Treatments: Drug: Indacaterol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00677807

CQAB149B2335SE

2008-000663-42 (EudraCT Number)

Details and patient eligibility

About

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Enrollment: 415 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).

• In addition the following inclusion/exclusion criteria specified below must be met.

  1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).
  2. Written informed consent to participate in the extension must be obtained.
  3. Patients must be able to comply with all study requirements.

Exclusion criteria

• Patients who were randomized to open-label tiotropium in Study B2335S.
• Patients who participated in Stage 1 of the core study (B2335S).
• Patients discontinued irrespective of the reason from Stage 2 of the core study.
• Patients who fail to comply with the core protocol requirements and procedures.
• Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
• Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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415 participants in 3 patient groups, including a placebo group

Indacaterol 150 µg

Experimental group

Description:

Indacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Indacaterol 300 µg

Experimental group

Description:

Indacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Placebo

Placebo Comparator group

Description:

Placebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo