Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 µg; Salmeterol 50 µg; Placebo to indacaterol; Placebo to salmeterol
Intervention description: Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).; Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).; Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1123.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: respiratory; dyspnea; breathlessness; COPD; indacaterol; long-acting β2-agonist

Summary:

      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.
    

Eligibility criteria:

        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.