Skip to main content
OpenTrials
Completed

NCT Number: NCT01061333

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nedocromil

Drug

Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge

Comparator: montelukast

Drug

Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge

Other names: Singulair

Comparator: mometasone

Drug

Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge

Placebo

Drug

Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet

Primary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Pre-allergen challenge and 20 minutes after allergen challenge

    Maximal percent drop in FEV1 at 20 minutes post allergen challenge

  2. Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes

    Time frame: Pre-allergen challenge and 5 minutes post allergen challenge

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

  3. Change in Plasma 9P at 20 Minutes

    Time frame: Pre-allergen challenge and 20 minutes post allergen challenge

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

Secondary outcomes

  1. Allergen-induced Changes in Urinary 9P

    Time frame: Baseline and 2 hours post allergen challenge

    Fold change over baseline in Urinary 9P at 2 hours post allergen challenge

  2. Allergen-induced Changes in Urinary Leukotriene (LT) E4

    Time frame: Baseline and 2 hours post allergen challenge

    Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge

  3. Allergen-induced Concentrations of Sputum LTC4

    Time frame: 2 hours post allergen challenge

    Concentrations of LTC4 in sputum at 2 hours post-allergen challenge

  4. Allergen-induced Concentrations of Sputum LTD4

    Time frame: 2 hours post allergen challenge

    Concentrations of LTD4 in sputum at 2 hours post-allergen challenge

  5. Allergen-induced Concentrations of Sputum LTE4

    Time frame: 2 hours post allergen challenge

    Concentrations of LTE4 in sputum at 2 hours post-allergen challenge

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 3, 2010
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.