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Combination DSCG and Reproterol

Phase 2

Asthma, Exercise-Induced | Small molecule | Respiratory |Viatris Inc.|Last Updated: Feb 7, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Clinical trial landscape

Combination DSCG and Reproterol · 1 trial · 1 indication

Phase 2 1
NCT00777348To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus ReproterolAsthma, Exercise-Induced
COMPLETED62 Analytics
PHASE2COMPLETED
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
Asthma, Exercise-Induced
NCT0077734862
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Study Endpoints

Primary Endpoints

Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA).
5, 10, 15, 30 and 60 minutes after drug application

Secondary Endpoints

Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo.
5, 10, 15, 30 and 60 minutes after drug application
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDSCG + Reproterol
2ACTIVE_COMPARATORDSCG
3ACTIVE_COMPARATORReproterol
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
Combination DSCG and ReproterolDRUG1:
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Female and male subjects aged 18 - 65 years * Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months) * Baseline F...

Countries:Germany
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Frequently asked questions about Combination DSCG and Reproterol

What is Combination DSCG and Reproterol used for?

Combination DSCG and Reproterol is an investigational small molecule being developed for the treatment of exercise-induced asthma. It is a fixed-dose combination of disodium cromoglycate and reproterol, designed to protect against exercise-induced bronchoconstriction in patients with asthma.

Who is developing Combination DSCG and Reproterol?

Combination DSCG and Reproterol is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical research on this fixed-dose combination for exercise-induced asthma.

What phase is Combination DSCG and Reproterol in?

Combination DSCG and Reproterol is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is Combination DSCG and Reproterol in?

Combination DSCG and Reproterol has one completed Phase 2 trial, NCT00777348, which assessed the protective effect of the fixed drug combination of disodium cromoglycate plus reproterol in 62 patients with exercise-induced asthma in Germany. The trial was randomized, double-blind, and placebo-controlled.

Is Combination DSCG and Reproterol the same as disodium cromoglycate plus reproterol?

Yes, Combination DSCG and Reproterol is the fixed drug combination of disodium cromoglycate (DSCG) plus reproterol. The clinical trial NCT00777348 evaluated this combination for its protective effect in exercise-induced asthma.