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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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

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

Participant Flow for 7 periods

Period 1: Period 1: Placebo Run-in

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Period 2: Period 2: 20-day Washout

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Period 3: Period 3: Nedocromil-Montelukast X-over

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Period 4: Period 4: 20-day Washout

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	8
COMPLETED	8	7
NOT COMPLETED	0	1
Discontinued by Study Team	0	1

Period 5: Period 5: Nedocromil-Montelukast X-over

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Period 6: Period 6: 20-day Washout

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

Period 7: Period 7: Mometasone

	Placebo-Montelukast-Nedocromil-Mometasone	Placebo-Nedocromil-Montelukast-Mometasone
STARTED	8	7
COMPLETED	8	7
NOT COMPLETED	0	0

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 ]

Show Outcome Measure 1

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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Measure Type	Secondary
Measure Title	Allergen-induced Concentrations of Sputum LTE4
Measure Description	Concentrations of LTE4 in sputum at 2 hours post-allergen challenge
Time Frame	2 hours post allergen challenge
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.

Reporting Groups

	Description
Placebo	Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
Nedocromil	Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
Montelukast	Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
Mometasone	Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge

Measured Values

	Placebo	Nedocromil	Montelukast	Mometasone
Number of Participants Analyzed [units: participants]	16	16	14	14
Allergen-induced Concentrations of Sputum LTE4 [units: pg/mL] Geometric Mean ± Standard Deviation	115.5 ± 129.0	149.8 ± 178.7	181.3 ± 227.6	140.3 ± 215.8

Statistical Analysis 1 for Allergen-induced Concentrations of Sputum LTE4

Groups ^[1]	Placebo vs. Nedocromil
Method ^[2]	ANOVA
P Value ^[3]	0.1983
Geom. mean of fold change over Placebo ^[4]	1.30
90% Confidence Interval	( 0.92 to 1.82 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	concentrations evaluated at log scale
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-Value not adjusted for simultaneous multiple comparisons
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Allergen-induced Concentrations of Sputum LTE4

Groups ^[1]	Placebo vs. Montelukast
Method ^[2]	ANOVA
P Value ^[3]	0.0872
Geom. mean of fold change over Placebo ^[4]	1.57
90% Confidence Interval	( 1.02 to 2.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	concentrations evaluated at log scale
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-Value not adjusted for simultaneous multiple comparisons
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Allergen-induced Concentrations of Sputum LTE4

Groups ^[1]	Placebo vs. Mometasone
Method ^[2]	ANOVA
P Value ^[3]	0.2499
Geom. mean of fold change over Placebo ^[4]	1.22
90% Confidence Interval	( 0.91 to 1.62 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	concentrations evaluated at log scale
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	p-Value not adjusted for simultaneous multiple comparisons
[4]	Other relevant estimation information:
	No text entered.

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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