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Nedocromil

Phase 1

Asthma | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Sep 4, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Nedocromil · 1 trial · 1 indication

Phase 1 1
NCT01061333Early Airway Response to Allergen in Asthmatics (MK-0000-176)Asthma
COMPLETED16 Analytics
PHASE1COMPLETED
Early Airway Response to Allergen in Asthmatics (MK-0000-176)
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Forced Expiratory Volume in 1 Second (FEV1)
Pre-allergen challenge and 20 minutes after allergen challenge

Maximal percent drop in FEV1 at 20 minutes post allergen challenge

Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
Pre-allergen challenge and 5 minutes post allergen challenge

Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge

Change in Plasma 9P at 20 Minutes
Pre-allergen challenge and 20 minutes post allergen challenge

Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge

Secondary Endpoints

Allergen-induced Changes in Urinary 9P
Baseline and 2 hours post allergen challenge
Allergen-induced Changes in Urinary Leukotriene (LT) E4
Baseline and 2 hours post allergen challenge
Allergen-induced Concentrations of Sputum LTC4
2 hours post allergen challenge
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboEXPERIMENTALPlacebo
MontelukastEXPERIMENTALMontelukast
NedocromilEXPERIMENTALNedocromil
MometasoneEXPERIMENTALMometasone

Interventions

NameTypeDescription
NedocromilDRUGNedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
Comparator: MontelukastDRUGMontelukast single 10 mg tablet administered 2 hours prior to allergen challenge
Comparator: MometasoneDRUGMometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge
PlaceboDRUGMometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * History of mild to moderate Asthma * In good general health (except for asthma) * Stable and free of respiratory infection * Nonsmoker * Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control) Exclusi...

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Frequently asked questions about Nedocromil

What is Nedocromil used for?

Nedocromil is a small molecule being investigated for the treatment of asthma. It is currently in Phase 1 clinical development. The drug is being studied for its effects on the early airway response to allergen in asthmatic patients.

Who makes Nedocromil?

Nedocromil is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.

What phase is Nedocromil in?

Nedocromil is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating asthma.

What clinical trials is Nedocromil in?

Nedocromil has one completed clinical trial registered as NCT01061333, titled "Early Airway Response to Allergen in Asthmatics (MK-0000-176)." This Phase 1 study enrolled 16 participants with asthma and was a randomized, double-blind, controlled trial.

Is Nedocromil FDA approved?

Nedocromil is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for asthma. The drug has completed one clinical trial, but it remains under investigation and has not received regulatory approval.