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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01061333
First received: February 1, 2010
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Nedocromil
Drug: Comparator: Montelukast
Drug: Comparator: Mometasone
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Pre-allergen challenge and 20 minutes after allergen challenge ] [ Designated as safety issue: No ]
    Maximal percent drop in FEV1 at 20 minutes post allergen challenge

  • Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes [ Time Frame: Pre-allergen challenge and 5 minutes post allergen challenge ] [ Designated as safety issue: No ]
    Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge

  • Change in Plasma 9P at 20 Minutes [ Time Frame: Pre-allergen challenge and 20 minutes post allergen challenge ] [ Designated as safety issue: No ]
    Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge


Secondary Outcome Measures:
  • Allergen-induced Changes in Urinary 9P [ Time Frame: Baseline and 2 hours post allergen challenge ] [ Designated as safety issue: No ]
    Fold change over baseline in Urinary 9P at 2 hours post allergen challenge

  • Allergen-induced Changes in Urinary Leukotriene (LT) E4 [ Time Frame: Baseline and 2 hours post allergen challenge ] [ Designated as safety issue: No ]
    Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge

  • Allergen-induced Concentrations of Sputum LTC4 [ Time Frame: 2 hours post allergen challenge ] [ Designated as safety issue: No ]
    Concentrations of LTC4 in sputum at 2 hours post-allergen challenge

  • Allergen-induced Concentrations of Sputum LTD4 [ Time Frame: 2 hours post allergen challenge ] [ Designated as safety issue: No ]
    Concentrations of LTD4 in sputum at 2 hours post-allergen challenge

  • Allergen-induced Concentrations of Sputum LTE4 [ Time Frame: 2 hours post allergen challenge ] [ Designated as safety issue: No ]
    Concentrations of LTE4 in sputum at 2 hours post-allergen challenge


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo
Placebo
Drug: Placebo
Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet
Experimental: Montelukast
Montelukast
Drug: Comparator: Montelukast
Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge
Other Name: Singulair
Experimental: Nedocromil
Nedocromil
Drug: Nedocromil
Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge
Experimental: Mometasone
Mometasone
Drug: Comparator: Mometasone
Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061333

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01061333     History of Changes
Other Study ID Numbers: 0000-176, 2010_507
Study First Received: February 1, 2010
Results First Received: April 26, 2012
Last Updated: August 7, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Nedocromil
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014