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QMF149 Twisthaler

Phase 2

Asthma | Small molecule | Respiratory |Novartis AG|Trials Updated: Aug 31, 2012

QMF149 Twisthaler development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,283

FDA Designations

No designations recorded

QMF149 Twisthaler clinical trials

QMF149 Twisthaler · 1 trial · 1 indication

Phase 2 1
NCT00941798Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With AsthmaAsthma
COMPLETED2,283 Analytics
PHASE2COMPLETED
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to First Serious Asthma Exacerbation
Up to 21 months

Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

Secondary Endpoints

Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
up to 21 months
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
Up to 21 months
Number of Patients With at Least One Asthma Worsening Post-baseline
Up to 21 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
QMF149 Twisthaler® 500/400EXPERIMENTALQMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Mometasone Twisthaler®ACTIVE_COMPARATORMometasone Twisthaler®, 400 µg QD

Interventions

NameTypeDescription
QMF149 Twisthaler®DRUGOnce daily via multi-dose dry-powder inhaler
Mometasone Twisthaler®DRUGOnce daily via multi-dose dry-powder inhaler
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Eligibility Criteria

Age Range12 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites146

Inclusion Criteria: * Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination * Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% ...

Countries:United StatesBrazilColombiaCzechiaHungaryIndiaPeruSlovakiaSouth Korea
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Frequently asked questions about QMF149 Twisthaler

What is QMF149 Twisthaler?

QMF149 Twisthaler is an investigational small molecule therapy developed by Novartis AG for the treatment of asthma. It is delivered as an inhaled combination product through the Twisthaler device and was studied in adolescent and adult patients with asthma. It remains in Phase 2 clinical development.

What is QMF149 Twisthaler used for?

QMF149 Twisthaler is being developed for the treatment of asthma in adolescent and adult patients aged 12 years and older. Its clinical program focused on respiratory care, and the drug has been studied in a Phase 2 trial evaluating safety in this patient population.

Who makes QMF149 Twisthaler?

QMF149 Twisthaler is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this inhaled asthma therapy.

What phase is QMF149 Twisthaler in?

QMF149 Twisthaler is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. One Phase 2 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is QMF149 Twisthaler in?

QMF149 Twisthaler was evaluated in the completed Phase 2 trial NCT00941798, titled Safety of QMF149 Twisthaler in Adolescent and Adult Patients With Asthma. The trial enrolled 2,283 patients across the United States, Brazil, Colombia, Czechia, Hungary, India, Peru, Slovakia, and South Korea.

Is QMF149 Twisthaler the same as QMF149 Twisthaler®?

Yes, QMF149 Twisthaler and QMF149 Twisthaler® refer to the same investigational asthma therapy from Novartis AG. The registered trademark symbol appears in the product name and in the title of its Phase 2 trial, but both names describe the identical drug candidate.