Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: indacaterol/glycopyrrolate; indacaterol; placebo
Intervention description: Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.; Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.; Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1

Summary:

      This study will evaluate the safety and efficacy of QVA149 in patients with moderate to
      severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior
             to initiation of any study-related procedure.

          2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD)
             according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines
             2006.

          3. Patients who have smoking history of at least 10 pack years.

          4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30%
             and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity
             (FVC) <0.70.

        Exclusion Criteria:

          1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether
             or not sexually active if they are not using acceptable methods of contraception.

          2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for
             chronic hypoxemia, or who have been hospitalized or visited an emergency department
             for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to
             screening.

          3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.

          4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed
             by chest x-ray to be no longer active) or clinically significant bronchiectasis.

          5. Patients with any history of asthma indicated by (but not limited to) a blood
             eosinophil count > 400/mm3.

          6. Patients who, in the judgment of the investigator or the responsible Novartis
             personnel, have a clinically relevant laboratory abnormality or a clinically
             significant condition.

          7. Patients with uncontrolled Type I and Type II diabetes.

          8. History of malignancy of any organ system (including lung cancer), treated or
             untreated, within the past 5 years.

          9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled
             anticholinergic agents.

         10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method)
             measured at screening is prolonged (>450 ms for males or >470 ms for females).

         11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled
             medication or any component thereof, or any of the study drugs or drugs with similar
             chemical structures.

        Other protocol-defined inclusion/exclusion criteria may apply.