Clinical trial NCT01012765: Effect of Indacaterol on Inspiratory Capacity (IC)
Official title: A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
indacaterol
QAB149
inspiratory capacity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 173
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Peak Inspiratory Capacity (IC) After 21 Days of Treatment
timeFrame: 21 days
Secondary outcomes:
measure: Trough IC After 20 Days of Treatment
timeFrame: 20 days
measure: Peak Residual Volume (RV) After 21 Days of Treatment
timeFrame: 21 days
measure: Peak Total Lung Capacity (TLC) After 21 Days of Treatment
timeFrame: 21 days
measure: Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
timeFrame: 21 days
measure: Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
timeFrame: 21 days
measure: FEV1 30 Minutes Post-dose After 21 Days of Treatment
timeFrame: 21 days
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
timeFrame: 20 days
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Geesthacht
country: Germany
facility: Novartis Investigative Site
city: Großhansdorf
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Neumünster
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Rathenow
country: Germany
facility: Novartis Investigative Site
city: Rüdersdorf
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigator Site
city: Zerbst
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Watz H, Krippner F, Kirsten A, Magnussen H, Vogelmeier C. Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease--a randomized, multicenter, double-blind, placebo-controlled study. BMC Pulm Med. 2014 Oct 4;14:158. doi: 10.1186/1471-2466-14-158.