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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01061333

First received: February 1, 2010

Last updated: April 26, 2012

Last verified: April 2012

History of Changes

Results First Received: April 26, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Nedocromil Drug: Comparator: Montelukast Drug: Comparator: Mometasone Drug: Placebo

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
All Participants	Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.

Baseline Measures

	All Participants
Number of Participants [units: participants]	16
Age [units: years] Mean ± Standard Deviation	31.94 ± 7.47
Gender [units: participants]
Female	4
Male	12

Outcome Measures

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1. Primary:

Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Pre-allergen challenge and 20 minutes after allergen challenge ]

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2. Primary:

Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes [ Time Frame: Pre-allergen challenge and 5 minutes post allergen challenge ]

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3. Primary:

Change in Plasma 9P at 20 Minutes [ Time Frame: Pre-allergen challenge and 20 minutes post allergen challenge ]

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4. Secondary:

Allergen-induced Changes in Urinary 9P [ Time Frame: Baseline and 2 hours post allergen challenge ]

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5. Secondary:

Allergen-induced Changes in Urinary Leukotriene (LT) E4 [ Time Frame: Baseline and 2 hours post allergen challenge ]

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6. Secondary:

Allergen-induced Concentrations of Sputum LTC4 [ Time Frame: 2 hours post allergen challenge ]

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7. Secondary:

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

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8. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: For multicenter studies, subsequent to the multicenter publication, an investigator and colleagues may publish their data independently. Limitations of single site observations should always be described in such a manuscript. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission. Any information identified by the SPONSOR as confidential must be deleted prior to submission.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

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

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