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QAB149

Phase 3

Chronic Obstructive Pulmonary Disease: COPD | Small molecule | Respiratory |Novartis AG|Last Updated: Feb 9, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

QAB149 · 4 trials · 3 indications

Phase 3 1Phase 2 2Phase 1 1
NCT01699685Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.Chronic Obstructive Pulmonary Disease: COPD
COMPLETED79 Analytics
PHASE3COMPLETED
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
Chronic Obstructive Pulmonary Disease: COPDUnlock trial analytics

Study Endpoints

Primary Endpoints

Inspiratory Capacity (IC) Peak Value
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).

Safety variables (laboratory tests, ECG, adverse events)
Pulmonary function measured between 22 and 24 hours after dosing on Day 1
Pharmacokinetic assessments of orally inhaled indacaterol will be made for up to 168 hours post dose for healthy subjects and for up to 240 hours post dose for patients with mild to moderate liver impairment.

Secondary Endpoints

Forced Expiratory Volume in One Second (FEV1)
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Inspiratory Capacity (IC)
within 4h after dosing
Forced Volume Capacity (FVC)
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence APLACEBO_COMPARATORPatients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
Sequence BACTIVE_COMPARATORPatients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
1EXPERIMENTALQAB149

Interventions

NameTypeDescription
QAB149DRUGCapsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
PlaceboDRUGCapsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
NVA237DRUGCapsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion criteria: * Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and \>10-pack year history of smoking * FEV1 \<80% and ≥30% of the predicted normal value who ...

Countries:SwitzerlandUnited States
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Frequently asked questions about QAB149

What is QAB149 used for in COPD?

QAB149 is an investigational small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is in Phase 2 clinical development and has been evaluated in dose-ranging and safety studies in patients with mild-to-moderate COPD. QAB149 is not FDA approved and remains in clinical development.

Who makes QAB149?

QAB149 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored multiple clinical trials evaluating QAB149 in patients with COPD and hepatic insufficiency.

What phase is QAB149 in?

QAB149 is in Phase 2 clinical development for chronic obstructive pulmonary disease (COPD). It has completed two Phase 2 trials and one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is QAB149 in?

QAB149 has completed several clinical trials, including NCT00098228, a dose-ranging study in 686 patients with COPD, and NCT00129831, a safety and tolerability study in 6 patients with mild-to-moderate COPD. A Phase 1 trial, NCT00416702, assessed the drug in healthy subjects and those with impaired liver function.

Is QAB149 the same as indacaterol?

Yes, QAB149 is also known as indacaterol. Clinical trial NCT00416702 is titled 'Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function,' confirming that QAB149 and indacaterol refer to the same compound.