A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
NCT ID: NCT00801853
Last Updated: 2011-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
424 participants
INTERVENTIONAL
2009-03-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aerovant 1
Aerovant 1mg bid
Aerovant
Aerovant 1mg bid (dry powder)
Aerovant 2
Aerovant 3mg bid
Aerovant
Aerovant 3mg bid (dry powder)
Aerovant 3
Aerovant 10mg bid
Aerovant
Aerovant 10mg bid (dry powder)
Placebo Control
Placebo Control
placebo
placebo control (dry powder)
Interventions
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Aerovant
Aerovant 1mg bid (dry powder)
Aerovant
Aerovant 3mg bid (dry powder)
Aerovant
Aerovant 10mg bid (dry powder)
placebo
placebo control (dry powder)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient satisfies, or has satisfied in the past, the GINA definition of moderate persistent to severe persistent asthma.
3. Patient has been maintained on moderate-to-high doses of ICS and LABA in the form of combination therapy or as individual agents (equivalent to fluticasone ≥ 250 mcg bid and salmeterol ≥ 50 mcg bid for ≥ 4 weeks before Screening \[Visit 1\]).
4. Patient has experienced an asthma exacerbation at least once in the past 2 years (defined here as use of physician prescribed oral corticosteroids or asthma requiring treatment increase approximately 4 times the baseline dose of inhaled corticosteroids or hospitalization due to asthma).
5. Patient has a pre-bronchodilator FEV1 ≥ 50% but ≤ 95% of the predicted value at both Screening (Visit 1) and Visit 2.
6. Patient demonstrates ≥ 12% reversibility (and a ≥ 200 mL difference) from prebronchodilator FEV1 within 15 to 30 minutes of receiving up to 4 puffs of a short-acting beta-agonist at Screening (Visit 1) or has ≥ 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of ≥ 12% within the previous 12 months (documented methacholine or histamine sensitivity (PC20) \<8mg/mL is also acceptable evidence or reversible airways disease).
7. Patient scores ≤ 20 on The Asthma Control Test™ at Screening (Visit 1) and Visit 2.
8. Female patient of childbearing potential or male patient and his female partner are practicing adequate and effective forms of contraception and agree to continue for the duration of the study. If female, must have a negative urine pregnancy test.
9. Patient has a pre-study medical history, physical examination, 12-Lead ECG, and safety laboratory test results within normal reference ranges or clinically acceptable to the Investigator.
10. Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a \< 10 pack/year history of smoking.
11. Patient is medically stable for at least 8 weeks before Randomization (Visit 2), and the Investigator does not consider study participation to place the patient at increased risk of AEs (with the exception of possible asthma exacerbations).
12. Patient is able and willing to give written informed consent.
Exclusion Criteria
2. Patient has received oral corticosteroid treatment within 8 weeks of Randomization (Visit 2)or patient has been intubated for ventilation in the past 5 years.
3. Patient has used any leukotriene antagonist within 1 week before Screening (Visit 1) or anti-IgE medications within 4 weeks of Screening (Visit 1).
4. Female patient is pregnant, breastfeeding, or not using an adequate method of contraception.
5. Patient has a clinically relevant medical history of very severs asthma that would preclude steroid reduction or sufficient compliance with the protocol.
6. Patient uses concomitant medications, including herbal, over-the-counter, or prescription medicines that, in the opinion of the Investigator, may affect the outcome of study endpoints and/or well-being of the patient.
7. Patient has a history of alcohol or substance abuse within 2 years of Screening (Visit 1).
8. Patient consumes more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1measure of spirits = ½ pint or 8 fluid ounces of beer).
9. Patient cannot communicate reliably with the Investigator or is unlikely to cooperate with the requirements of the study.
10. Patient has previously taken AEROVANT™ or another formulation of AER 001 (e.g., BAY 16-9996, pitrakinra).
11. Patient has participated in any clinical trial involving use of an investigational drug within 12 weeks of first dose of study drug.
18 Years
ALL
No
Sponsors
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Aerovance, Inc.
INDUSTRY
Responsible Party
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Aerovance, Inc.
Principal Investigators
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Sally Wenzel, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Pulmonary Associates of Mobile, P.C.
Mobile, Alabama, United States
Allergy and Immunology Associates Ltd
Scottsdale, Arizona, United States
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States
Allergy Associates Medical Group Inc.
San Diego, California, United States
Institute of Healthcare Assessment Inc.
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Allergy and Asthma Clinical Research Inc.
Walnut Creek, California, United States
Colorado Asthma and Allergy Research Centers, P.C.
Centenniel, Colorado, United States
Asthma and Allergy Associates P.C. and Research Center
Colorado Springs, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Florida Center for Asthma and Allergy Research
Miami, Florida, United States
Allergy and Asthma Diagnostic Treatment Center
Tallahassee, Florida, United States
Partners in Asthma and Allergy Care, P.A.
Valrico, Florida, United States
Pulmonary Consultants of North Idaho
Coeur d'Alene, Idaho, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Allergy and Clinical Immunology
Bangor, Maine, United States
The Brigham and Womens Hospital Inc.
Boston, Massachusetts, United States
North East Medical Research Associates, Inc
North Dartmouth, Massachusetts, United States
Cardiopulmonary Associates of Missoula
Missoula, Montana, United States
Pulmonary and Allergy Associates
Summit, New Jersey, United States
ENT and Allergy Associates
Newburgh, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
IPS Research
Oklahoma City, Oklahoma, United States
Allergy and Asthma Associates/Oak Street Medical P.C.
Eugene, Oregon, United States
Allergy Associates Research Center
Portland, Oregon, United States
Asthma and Allergy Research of New Jersey Inc.
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Asthma and Allergy Research Associates, PA
Upland, Pennsylvania, United States
Asthma, Nasal Disease and Allergy Research Center of New England
Providence, Rhode Island, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Allergy and Asthma Research Center, P.A.
San Antonio, Texas, United States
Discovery Clinical Trials, LLC
San Antonio, Texas, United States
Johnston Memorial Hospital
Abingdon, Virginia, United States
Dr. Kenessey Albert Kórház - Rendelőintézet
Balassagyarmat, , Hungary
Gyógyír XI Kht ( XI Kerületi Tüdőgondozó)
Budapest, , Hungary
Margit Kórház
Csorna, , Hungary
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
Deszk, , Hungary
Érd Városi Önkormányzat Szakorvosi Rendelőintézet
Érd, , Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
Nyíregyháza, , Hungary
Siofok Varos Korhaz-Rendelointezet
Siófok, , Hungary
Szarvasi Tüdőgyógyász Kft.
Szarvas, , Hungary
Men For Care Kft. Százhalom Egészségügyi Központ
Százhalombatta, , Hungary
Vas Megyei Markusovszky Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház
Szombathely, , Hungary
Komárom-Esztergom Megyei Önkormányzat Szent Borbála Kórháza
Tatabánya, , Hungary
Prywatny Gabinet Internistyczno - Alergologiczny
Bialystok, , Poland
10 Wojskowy Szpital Kliniczny z Poliklinika Kliniczny Oddzial Pulmonologiczny
Bydgoszcz, , Poland
Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej
Bystra, , Poland
Medcare NZOZ
Gdansk, , Poland
All-Med
Krakow, , Poland
NZOZ Centrum Alergologii prof. Krzysztof Buczylko
Lodz, , Poland
Poradnia Alergologii i Chorob Pluc SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlicki
Lodz, , Poland
AlergoTest SC
Lublin, , Poland
NZOZ Centrum Medyczne Lucyna Andrzej Dymek
Strzelce Opolskie, , Poland
Alergomed Specjalistyczna Przychodnia Lekarska sp zoo
Tarnów, , Poland
Barnsley District Hospital
Barnsley, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Queens Hospital
Burton-on-Trent, , United Kingdom
Woolpit Health Centre
Bury St Edmunds, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Avondale Surgery
Chesterfield, , United Kingdom
Chesterfield Royal Hospital
Chesterfield, , United Kingdom
Colchester General Hospital
Colchester, , United Kingdom
Gartnavel General Hospital
Glasgow, , United Kingdom
Glenfield Hospital
Leicester, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Countries
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References
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Slager RE, Otulana BA, Hawkins GA, Yen YP, Peters SP, Wenzel SE, Meyers DA, Bleecker ER. IL-4 receptor polymorphisms predict reduction in asthma exacerbations during response to an anti-IL-4 receptor alpha antagonist. J Allergy Clin Immunol. 2012 Aug;130(2):516-22.e4. doi: 10.1016/j.jaci.2012.03.030. Epub 2012 Apr 26.
Other Identifiers
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PPD/2007/AER 001 DPI/2b
Identifier Type: -
Identifier Source: org_study_id
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