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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01061333
First Posted: February 3, 2010
Last Update Posted: September 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Concentrations of LTC4 in sputum at 2 hours post-allergen challenge

  • Allergen-induced Concentrations of Sputum LTD4 [ Time Frame: 2 hours post allergen challenge ]
    Concentrations of LTD4 in sputum at 2 hours post-allergen challenge

  • Allergen-induced Concentrations of Sputum LTE4 [ Time Frame: 2 hours post allergen challenge ]
    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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061333


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01061333     History of Changes
Other Study ID Numbers: 0000-176
2010_507 ( Other Identifier: Merck )
First Submitted: February 1, 2010
First Posted: February 3, 2010
Results First Submitted: April 26, 2012
Results First Posted: May 28, 2012
Last Update Posted: September 4, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Montelukast
Nedocromil
Mometasone Furoate
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents