A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol; Drug: Tiotropium; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615459

CQAB149B2331

Details and patient eligibility

About

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with chronic obstructive pulmonary disease.

Enrollment: 169 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

• Co-operative out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:

  1. Smoking history of at least 10 pack years (current or previous smokers)
  2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥30% of the predicted normal value.
  3. Post-bronchodilator FEV1/Forced vital capacity (FVC) < 70%

Exclusion criteria

• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
• Patients requiring long-term oxygen therapy for chronic hypoxemia
• Patients who have had a respiratory tract infection within 6 weeks prior to Visit
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
• Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
• Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
• Patients unable to successfully use a dry powder inhaler device, MDI or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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169 participants in 4 patient groups

Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg

Experimental group

Description:

In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Drug: Tiotropium

Drug: Placebo

Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium

Experimental group

Description:

In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Drug: Tiotropium

Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo

Experimental group

Description:

In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Drug: Placebo

Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg

Experimental group

Description:

In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.

Treatment:

Drug: Indacaterol

Drug: Tiotropium

Drug: Placebo