Phase 1 N=16 Randomized Double-blind Treatment

Early Airway Response to Allergen in Asthmatics (MK-0000-176)

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT01061333 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Change in Forced Expiratory Volume in 1 Second (FEV1) — -24.66; -8.44; -9.15; -16.17 Percentage drop in FEV1 — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Nedocromil (Drug); Comparator: Montelukast (Drug); Comparator: Mometasone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Forced Expiratory Volume in 1 Second (FEV1)	-24.66; -8.44; -9.15; -16.17	<0.0001 sig
PRIMARY Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes	0.77; 0.97; 1.08; 1.00	0.0430 sig
PRIMARY Change in Plasma 9P at 20 Minutes	1.22; 0.72; 0.72; 1.06	<0.0001 sig
SECONDARY Allergen-induced Changes in Urinary 9P	1.54; 1.39; 1.45; 1.40	0.7622
SECONDARY Allergen-induced Changes in Urinary Leukotriene (LT) E4	1.77; 1.19; 1.40; 1.62	0.0006 sig
SECONDARY Allergen-induced Concentrations of Sputum LTC4	13.63; 14.02; 13.76; 12.14	0.7501
SECONDARY Allergen-induced Concentrations of Sputum LTD4	17.48; 18.04; 18.52; 17.37	0.8616
SECONDARY Allergen-induced Concentrations of Sputum LTE4	115.5; 149.8; 181.3; 140.3	0.1983

Summary

This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.

Eligibility Criteria

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)

Exclusion Criteria

Nursing mother
Recent or ongoing upper or lower respiratory tract infection
Unable to refrain from or anticipates the use of any prescription and non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
History of stroke, chronic seizures, or major neurological disorder
History of cancer
Received a vaccination within the past 3 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01061333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.