A 52-WEEK TREATMENT, MULTI-CENTER, RANDOMIZED, DOUBLEBLIND,DOUBLE DUMMY, PARALLEL-GROUP, ACTIVE CONTROLLEDSTUDY TO COMPARE THE EFFECT OF QVA149 (INDACATEROL MALEATE/ GLYCOPYRRONIUM BROMIDE) WITH SALMETEROL/FLUTICASONE ONTHE RATE OF EXACERBATIONS IN SUBJECTS WITH MODERATE TO VERYSEVERE COPD

Not Applicable

• Conditions: -J44 Other chronic obstructive pulmonary disease; Other chronic obstructive pulmonary disease; J44

• Registration Number: PER-068-13
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Written informed consent must be obtained before any assessment is performed.
2. Male or female adults aged ≥40 years.
3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
5. Patients with a post-bronchodilator FEV1 ≥25 and < 60% of the predicted normal value,
and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
(Post refers to 1 h after sequential inhalation of 84 μg (or equivalent dose) of ipratropium
bromide and 400 μg of salbutamol).
6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
required treatment with systemic glucocorticosteroids and/or antibiotics.
7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).

Exclusion Criteria

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
hCG (human Chorionic Gonadotropin) laboratory test.
Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment. Effective contraception methods include.
Patients with Type I or uncontrolled Type II diabetes.
4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101
(Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a
central assessor. These patients should not be re-screened.
5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201.
(These patients should not be re-screened)
6. Patients who have a clinically significant laboratory abnormality at Visit 101.
7. Patients who have clinically significant renal, cardiovascular (such as but not limited to
unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial
infarction), arrhythmia (see below for patients with atrial fibrillation), neurological,
endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
abnormalities which could interfere with the assessment of the efficacy and safety of the
study treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified