A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
A Phase IIb Study to Investigate the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients Not Fully Controlled on Current Therapy
1 other identifier
interventional
424
4 countries
71
Brief Summary
A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group, repeated-dose study in male and female patients with moderate to severe asthma in which patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared to placebo. Incidence of asthma exacerbation is the primary endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Mar 2009
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJanuary 27, 2011
November 1, 2009
11 months
December 1, 2008
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of exacerbation
4 months
Secondary Outcomes (9)
In-clinic and daily pulmonary function
4 months
Time to exacerbation after randomization
4 months
Change from baseline in daily asthma symptom scores
4 months
Change from baseline in daily beta-agonist reliever use
4 months
Change from baseline in total IgE
4 months
- +4 more secondary outcomes
Study Arms (4)
Aerovant 1
EXPERIMENTALAerovant 1mg bid
Aerovant 2
EXPERIMENTALAerovant 3mg bid
Aerovant 3
EXPERIMENTALAerovant 10mg bid
Placebo Control
PLACEBO COMPARATORPlacebo Control
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patient, ≥ 18 years of age with a documented clinical history of asthma, has been treated for asthma and, in the opinion of the Investigator, is not fully controlled on current asthma therapy.
- Patient satisfies, or has satisfied in the past, the GINA definition of moderate persistent to severe persistent asthma.
- 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 \[Visit 1\]).
- 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).
- Patient has a pre-bronchodilator FEV1 ≥ 50% but ≤ 95% of the predicted value at both Screening (Visit 1) and Visit 2.
- 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).
- Patient scores ≤ 20 on The Asthma Control Test™ at Screening (Visit 1) and Visit 2.
- 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.
- 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.
- Patient is a non-smoker for at least 6 months before Screening (Visit 1) and has a \< 10 pack/year history of smoking.
- 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).
- Patient is able and willing to give written informed consent.
You may not qualify if:
- Patient has a current diagnosis of respiratory disorder other than asthma (e.g., chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary disease \[COPD\], etc).
- 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.
- Patient has used any leukotriene antagonist within 1 week before Screening (Visit 1) or anti-IgE medications within 4 weeks of Screening (Visit 1).
- Female patient is pregnant, breastfeeding, or not using an adequate method of contraception.
- Patient has a clinically relevant medical history of very severs asthma that would preclude steroid reduction or sufficient compliance with the protocol.
- 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.
- Patient has a history of alcohol or substance abuse within 2 years of Screening (Visit 1).
- 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).
- Patient cannot communicate reliably with the Investigator or is unlikely to cooperate with the requirements of the study.
- Patient has previously taken AEROVANT™ or another formulation of AER 001 (e.g., BAY 16-9996, pitrakinra).
- Patient has participated in any clinical trial involving use of an investigational drug within 12 weeks of first dose of study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aerovance, Inc.lead
Study Sites (71)
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, 15213, 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
Related Publications (1)
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.
PMID: 22541248DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sally Wenzel, M.D.
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 4, 2008
Study Start
March 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
January 27, 2011
Record last verified: 2009-11