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

Asthma Clinical Trial

Official title:

A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061333
• Other study ID #: 0000-176
• Secondary ID: 2010_507
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2010
• Last updated: September 3, 2015
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Nedocromil
Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
• Comparator: Montelukast
Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge
• Comparator: Mometasone
Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge
• Placebo
Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Forced Expiratory Volume in 1 Second (FEV1)	Maximal percent drop in FEV1 at 20 minutes post allergen challenge	Pre-allergen challenge and 20 minutes after allergen challenge	No
Primary	Change in Plasma 9a-11ß-PGF2 (9P) at 5 Minutes	Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge	Pre-allergen challenge and 5 minutes post allergen challenge	No
Primary	Change in Plasma 9P at 20 Minutes	Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge	Pre-allergen challenge and 20 minutes post allergen challenge	No
Secondary	Allergen-induced Changes in Urinary 9P	Fold change over baseline in Urinary 9P at 2 hours post allergen challenge	Baseline and 2 hours post allergen challenge	No
Secondary	Allergen-induced Changes in Urinary Leukotriene (LT) E4	Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge	Baseline and 2 hours post allergen challenge	No
Secondary	Allergen-induced Concentrations of Sputum LTC4	Concentrations of LTC4 in sputum at 2 hours post-allergen challenge	2 hours post allergen challenge	No
Secondary	Allergen-induced Concentrations of Sputum LTD4	Concentrations of LTD4 in sputum at 2 hours post-allergen challenge	2 hours post allergen challenge	No
Secondary	Allergen-induced Concentrations of Sputum LTE4	Concentrations of LTE4 in sputum at 2 hours post-allergen challenge	2 hours post allergen challenge	No