A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: short acting β2- agonist; Drug: formoterol; Drug: placebo to formoterol; Drug: placebo to indacaterol; Drug: indacaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557466

CQMF149B2201

Details and patient eligibility

About

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

Enrollment: 568 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)

• Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

  • Smoking history of at least 10 pack years
  • Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.
  • Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

Exclusion criteria

• Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
• Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
• Patients with a history of asthma.
• Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
• Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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568 participants in 6 patient groups, including a placebo group

indacaterol 62.5 μg

Experimental group

Description:

Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to formoterol

Drug: indacaterol

indacaterol 125 μg

Experimental group

Description:

Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to formoterol

Drug: indacaterol

Indacaterol 250 μg

Experimental group

Description:

Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to formoterol

Drug: indacaterol

indacaterol 500 μg

Experimental group

Description:

Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to formoterol

Drug: indacaterol

formoterol

Active Comparator group

Description:

Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to indacaterol

Drug: formoterol

placebo

Placebo Comparator group

Description:

Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication.

Treatment:

Drug: short acting β2- agonist

Drug: placebo to formoterol

Drug: placebo to indacaterol