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Combination DSCG and Reproterol

Phase 2

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

Combination DSCG and Reproterol development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment62

FDA Designations

No designations recorded

Combination DSCG and Reproterol clinical trials

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-InducedUnlock trial analytics

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 the combination of DSCG and reproterol used for?

The fixed-dose combination of disodium cromoglycate (DSCG) and reproterol is being studied for exercise-induced asthma. It is designed to protect against bronchoconstriction triggered by physical activity. The combination is a small-molecule therapy delivered as a fixed-dose product and is in Phase 2 development.

Who is developing the combination of DSCG and reproterol?

Viatris Inc. (ticker: VTRS) is the developer of the fixed-dose combination of disodium cromoglycate and reproterol. Viatris is a global pharmaceutical company, and this asset is part of its respiratory pipeline.

What phase is the combination of DSCG and reproterol in?

The combination of DSCG and reproterol is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.

What clinical trials has the combination of DSCG and reproterol been studied in?

The combination has been evaluated in a single Phase 2 trial, NCT00777348, titled "To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol." The trial enrolled 62 participants with exercise-induced asthma in Germany. It was randomized, double-blind, and placebo-controlled, and it has been completed.