Effect of Indacaterol on Inspiratory Capacity (IC)

Novartis Pharmaceuticals173 enrolled

Overview

This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

173

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

IndacaterolDRUG

Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)

TiotropiumDRUG

Tiotropium 18µg o.d. delivered via a proprietary inhalation device.

PlaceboDRUG

Placebo to indacaterol o.d. delivered via SDDPI

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including: * Smoking history of at least 10 pack years * Post-bronchodilator FEV1 \<80% and ≥50% of the predicted normal value (Visit 2). * Post-bronchodilator FEV1/forced vital capacity (FVC) \<70% (Visit 2). Exclusion Criteria: * Patients who received any corticosteroid (including inhaled) for 3 months prior to screening Other protocol-defined inclusion/exclusion criteria may apply

Locations (21)

Novartis Investigative Site

Aschaffenburg, Germany

Novartis Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

Peak Inspiratory Capacity (IC) After 21 Days of Treatment

IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.

Time frame: 21 days

Secondary Outcomes

Trough IC After 20 Days of Treatment

Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.

Time frame: 20 days

Peak Residual Volume (RV) After 21 Days of Treatment

Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.

Time frame: 21 days

Peak Total Lung Capacity (TLC) After 21 Days of Treatment

TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center.

Time frame: 21 days

Data from ClinicalTrials.gov

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