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cilomilast

Phase 3

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Oct 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

cilomilast · 1 trial · 1 indication

Phase 3 1
NCT00103922Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)Pulmonary Disease, Chronic Obstructive
COMPLETED600 Analytics
PHASE3COMPLETED
Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

measure of lung function and quality of life in patients with COPD

Secondary Endpoints

exacerbations in patients with COPD
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
cilomilastDRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites115

Inclusion criteria: * Diagnosis of COPD and a history of cigarette smoking. Exclusion criteria: * Significant heart or lung disease not associated with COPD. * Significant stomach or intestinal disease.

Countries:United States
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Frequently asked questions about cilomilast

What is cilomilast used for?

Cilomilast is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is intended for patients with this respiratory condition, which involves airflow obstruction and breathing difficulties. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved for use.

Who makes cilomilast?

Cilomilast is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with chronic obstructive pulmonary disease.

What phase is cilomilast in?

Cilomilast is in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The drug is being studied for chronic obstructive pulmonary disease, and it remains investigational, meaning it is not yet approved by regulatory authorities.

What clinical trials is cilomilast in?

Cilomilast has one completed Phase 3 clinical trial with the identifier NCT00103922. This study enrolled 600 participants with chronic obstructive pulmonary disease in the United States. The trial was randomized and double-blind, and it has been completed, with no active trials currently ongoing.

Is cilomilast FDA approved?

Cilomilast is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for chronic obstructive pulmonary disease. The drug has completed a Phase 3 trial, but it has not yet received approval from the FDA or other regulatory agencies.