An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)

Novartis27 enrolled

Overview

This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol 300μgDRUG

300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device

PlaceboDRUG

Matching placebo devices and hard gelatin capsules

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female subjects, * 40 to 80 years of age, * with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC \< 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol) * Subjects who demonstrate a plethysmographic functional residual capacity \>120% predicted normal Exclusion Criteria: * No COPD exacerbations within 6 weeks prior to dosing, * no concomitant lung disease such as asthma, * no requirement for long term oxygen treatment or history of lung reduction surgery. * No medical conditions that would interfere with the performance of spirometry or clinical exercise testing. * Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease Other protocol-defined inclusion/exclusion criteria may apply

Locations (3)

Novartis Investigator Site

Berlin, Germany

Novartis Investigator Site

Mönchengladbach, Germany

Novartis Investigator Site

Wiesbaden, Germany

Outcomes

Primary Outcomes

Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14

Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.

Time frame: Day 14

Secondary Outcomes

Static Inspiratory Capacity (IC) at Day 14

Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,

Time frame: Day 14

Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.

Time frame: Day 14

Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14

Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.

Data from ClinicalTrials.gov

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