A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

This study is currently recruiting participants.

Verified by Genentech, March 2009

First Received: October 27, 2008 Last Updated: March 3, 2009 History of Changes

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00781443

Purpose

This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.

Condition	Intervention	Phase
Allergic Asthma	Drug: MILR1444A Drug: placebo	Phase II

MedlinePlus related topics: Asthma Choking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment
Official Title:	A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma

Further study details as provided by Genentech:

Primary Outcome Measures:

Late asthmatic response (LAR) [ Time Frame: Day 92 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Early asthmatic response (EAR) [ Time Frame: Day 92 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	December 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: MILR1444A Repeating subcutaneous injection
B: Placebo Comparator	Drug: placebo Repeating subcutaneous injection

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet criteria for the diagnosis of allergic asthma
Diagnosis of asthma ≥ 6 months
Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
Body weight between 40-120 kg
Normal chest X-ray within 2 years of screening

Exclusion Criteria:

Require daily controller medication for asthma
History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
Documented medical history of anaphylaxis
Immunotherapy currently or within the past 3 months prior to screening
Lung disease other than mild allergic asthma
Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
Pregnant or lactating
Significant concurrent medical illness other than asthma
Clinically significant abnormality on ECG at the screening visit
Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
History of helminthic infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781443

Contacts

Contact: Todd Clobes

clobes.todd@gene.com

Locations

United States, California
Allergy Research Foundation	Recruiting
Los Angeles, California, United States, 90025
Contact: Tamara Johnson 310-477-1734 ext 232 johnsontam@sbcglobal.net
West Coast Clinical Trials	Recruiting
Long Beach, California, United States, 90806
Contact: Maria Chona Kemp 562-997-8850 mariak@wcctrials2-4.com
United States, Missouri
Clinical Research Center LLC	Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Kelly Esposito 314-514-8509 k.esposito@clinicalresearchcenter.com
Washington Univ School of Med	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tammy Koch 314-747-3063 tkoch@im.wustl.edu
United States, North Carolina
Duke Univ Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeanne Woodard 919-668-0288 jeanne.woodard@duke.edu
United States, Wisconsin
Univ of Wisconsin-Madison	Recruiting
Madison, Wisconsin, United States, 53762
Contact: Jurga Zdanaviciene 608-263-6185 jxz@medicine.wisc.edu

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Edward Conner, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ILR4544g
Study First Received:	October 27, 2008
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00781443 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Insufficiency
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Hypersensitivity, Immediate
Asthma
Airway Obstruction
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Insufficiency
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Hypersensitivity, Immediate
Asthma
Airway Obstruction
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009