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cilomilast

Phase 3

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

cilomilast development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Feb 2005

cilomilast target and mechanism

Molecular targetPDE4A, PDE4D, PDE4B, PDE4C
Target classInhibitor
ModalitySmall molecule

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

cilomilast clinical trials

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 developed for chronic obstructive pulmonary disease (COPD), a respiratory condition. It was studied in adults aged 40 years and older with COPD. Cilomilast has not been approved for marketing and remains in clinical development for this indication.

What does cilomilast target?

Cilomilast is a phosphodiesterase 4 (PDE4) inhibitor. It targets the PDE4 enzyme subtypes PDE4A, PDE4B, PDE4C, and PDE4D. By inhibiting these enzymes, cilomilast is designed to modulate inflammatory signaling associated with chronic obstructive pulmonary disease.

Who makes cilomilast?

Cilomilast is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical development program for the drug in chronic obstructive pulmonary disease.

What phase is cilomilast in?

Cilomilast reached Phase 3 clinical development for chronic obstructive pulmonary disease. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed.

What clinical trials is cilomilast in?

Cilomilast was evaluated in the Phase 3 trial NCT00103922, titled Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease). The trial enrolled 600 participants, was randomized and double blind, and was conducted in the United States. It is listed as completed, with no active trials ongoing.