Effect of Indacaterol on Inspiratory Capacity (IC)

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012765
• Other study ID #: CQAB149BDE01
• Secondary ID: EUDRACT No.: 200
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2009
• Last updated: February 16, 2016
• Start date: November 2009

Study information

• Verified date: February 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• Indacaterol
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
• Tiotropium
Tiotropium 18µg o.d. delivered via a proprietary inhalation device.
• Placebo
Placebo to indacaterol o.d. delivered via SDDPI

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aschaffenburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative site	Frankfurt am Main
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Geesthacht
Germany	Novartis Investigative Site	Großhansdorf
Germany	Novartis Investigative Site	Halle
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koblenz
Germany	Novartis Investigative site	Leipzig
Germany	Novartis Investigative Site	Mannheim
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Neumünster
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Rathenow
Germany	Novartis Investigative Site	Rüdersdorf
Germany	Novartis Investigator Site	Witten
Germany	Novartis Investigative Site	Zerbst

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 days	No
Secondary	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.	20 days	No
Secondary	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.	21 days	No
Secondary	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.	21 days	No
Secondary	Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment	Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.	21 days	No
Secondary	Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment	Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three 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.	21 days	No
Secondary	FEV1 30 Minutes Post-dose After 21 Days of Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.	21 days	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center.	20 days	No