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QMF149 Twisthaler

Phase 2

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

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

Clinical trial landscape

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 used for in asthma?

QMF149 Twisthaler is an investigational small molecule being developed for the treatment of asthma. It is delivered via the Twisthaler device. As of the available data, it is in Phase 2 clinical development and is not approved by regulatory authorities.

Who makes QMF149 Twisthaler?

QMF149 Twisthaler is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for asthma.

What phase is QMF149 Twisthaler in?

QMF149 Twisthaler is in Phase 2 clinical development. It is an investigational drug for asthma and has not received regulatory approval. One Phase 2 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is QMF149 Twisthaler in?

QMF149 Twisthaler has been studied in one completed Phase 2 clinical trial, identified as NCT00941798. This trial, titled "Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma," enrolled 2,283 participants across multiple countries including the United States, Brazil, and India.

Is QMF149 Twisthaler the same as any other drug?

QMF149 Twisthaler is the specific name of the drug product developed by Novartis. The Twisthaler refers to the inhalation device used to deliver the medication. No alternative drug names have been reported in the available clinical trial information.