Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD) (INSIST)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo to indacaterol; Drug: Placebo to salmeterol; Drug: Indacaterol 150 µg; Drug: Salmeterol 50 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821093

2008-005146-23 (EudraCT Number)

CQAB149B2349

Details and patient eligibility

About

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Enrollment: 1,123 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥ 40 years

• Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) and:

  • Smoking history of at least 10 pack years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value at screening
  • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70% at screening

Exclusion criteria

• Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
• Patients requiring long-term oxygen therapy (> 15 h a day) for chronic hypoxemia
• Patients who have had a respiratory tract infection within 6 weeks prior to screening
• 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 (Fridericia's) measured at screening 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 or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,123 participants in 2 patient groups

Indacaterol 150 µg

Experimental group

Description:

Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to salmeterol

Drug: Indacaterol 150 µg

Salmeterol 50 µg

Active Comparator group

Description:

Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Treatment:

Drug: Placebo to indacaterol

Drug: Salmeterol 50 µg