NCT01012765|CompletedPhase 3Results

Effect of Indacaterol on Inspiratory Capacity (IC)

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

Novartis Pharmaceuticals ClinicalTrials.gov

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2 other identifiers

CQAB149BDE01EUDRACT No.: 2009-013686-26

Study Type

interventional

Target

173

Locations

1 country

Sites

Timeline

RegisteredNov 2009

StartedNov 2009

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

173

participants targeted

Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach

1 country

21 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed

10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2009

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

February 17, 2012

Completed

Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

November 11, 2009

Results QC Date

January 17, 2012

Last Update Submit

February 16, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDindacaterolQAB149inspiratory capacity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

Trough IC After 20 Days of Treatment
20 days
Peak Residual Volume (RV) After 21 Days of Treatment
21 days
Peak Total Lung Capacity (TLC) After 21 Days of Treatment
21 days
Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
21 days
Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
21 days
+2 more secondary outcomes

Study Arms (6)

Indacaterol - placebo - tiotropium

EXPERIMENTAL

In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.