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QAX028

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |Novartis AG|Last Updated: Dec 19, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

QAX028 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT01068613Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED62 Analytics
PHASE2COMPLETED
Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium
7 days treatment
Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo.
throughout the study

Secondary Endpoints

Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium
7 days treatment
Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo
7 days treatment
Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients
7 days treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QAX028 high doseEXPERIMENTAL -
QAX028 low doseEXPERIMENTAL -
TiotropiumACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
1ACTIVE_COMPARATORQAX028 high dose
2PLACEBO_COMPARATORPlacebo
3ACTIVE_COMPARATORTiotropium bromide
4ACTIVE_COMPARATORQAX028 medium dose
5ACTIVE_COMPARATORQAX028 low dose

Interventions

NameTypeDescription
QAX028DRUGQAX028 60 mcg via inhalation device
TiotropiumDRUGTiotropium via inhalation device
PlaceboDRUGPlacebo to QAX028 via inhalation device
Tiotropium bromideDRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosis of COPD according to GOLD guidelines * Post-bronchodilator 30%≤FEV1\<80% of predicted normal and ost-bronchodilator FEV1/FVC \<0.7 * Smoking history of at least 10 pack years Exclusion Criteria: * Requiring oxygen therapy on a daily basis * Exacerbation of airway d...

Countries:United StatesDenmark
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Frequently asked questions about QAX028

What is QAX028 used for in COPD?

QAX028 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It has been studied in patients with mild-to-moderate COPD to evaluate its safety, tolerability, and pharmacodynamics, as well as its efficacy compared with placebo and an active control.

Who makes QAX028?

QAX028 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. Novartis has sponsored clinical trials of QAX028 in patients with COPD.

What phase is QAX028 in?

QAX028 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial assessed safety and tolerability, while the Phase 2 trial evaluated safety and efficacy of multiple doses. Both trials are completed, and QAX028 remains an investigational drug.

What clinical trials has QAX028 been in?

QAX028 has been studied in two completed clinical trials. The first, NCT00568503, was a Phase 1 trial in Denmark enrolling 29 patients with mild-to-moderate COPD. The second, NCT01068613, was a Phase 2 trial in the United States enrolling 62 patients with COPD.

Is QAX028 the same as tiotropium bromide?

No, QAX028 is not the same as tiotropium bromide. In a Phase 1 trial, QAX028 was compared with open-label tiotropium bromide and placebo to assess its safety, tolerability, and pharmacodynamics in patients with mild-to-moderate COPD. QAX028 is a separate investigational compound.