A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL
- Registration Number
- NCT00801853
- Lead Sponsor
- Aerovance, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 424
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control placebo Placebo Control Aerovant 2 Aerovant Aerovant 3mg bid Aerovant 1 Aerovant Aerovant 1mg bid Aerovant 3 Aerovant Aerovant 10mg bid
- Primary Outcome Measures
Name Time Method Incidence of exacerbation 4 months
- Secondary Outcome Measures
Name Time Method 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 Change from baseline in fractional concentration of expired nitric oxide (FENO) 4 months Population pharmacokinetics 4 months SNP analysis for IL-4 and IL-13 relevant genes (Exploratory) 4 months General safety evaluation including lung function, blood pressure, heart rate, respiratory rate, temperature, ECG parameters, safety laboratory tests. 4 months
Trial Locations
- Locations (71)
Alergomed Specjalistyczna Przychodnia Lekarska sp zoo
🇵🇱Tarnów, Poland
Asthma and Allergy Research of New Jersey Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Allergy and Clinical Immunology
🇺🇸Bangor, Maine, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Morriston Hospital
🇬🇧Swansea, United Kingdom
Allergy Associates Medical Group Inc.
🇺🇸San Diego, California, United States
Allergy and Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Institute of Healthcare Assessment Inc.
🇺🇸San Diego, California, United States
Allergy and Immunology Associates Ltd
🇺🇸Scottsdale, Arizona, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy and Asthma Diagnostic Treatment Center
🇺🇸Tallahassee, Florida, United States
Cardiopulmonary Associates of Missoula
🇺🇸Missoula, Montana, United States
Asthma and Allergy Associates P.C. and Research Center
🇺🇸Colorado Springs, Colorado, United States
Pulmonary and Allergy Associates
🇺🇸Summit, New Jersey, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, 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
Dr. Kenessey Albert Kórház - Rendelőintézet
🇭🇺Balassagyarmat, Hungary
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
🇭🇺Nyiregyhaza, Hungary
Siofok Varos Korhaz-Rendelointezet
🇭🇺Siofok, Hungary
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
Barnsley District Hospital
🇬🇧Barnsley, United Kingdom
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
All-Med
🇵🇱Krakow, Poland
NZOZ Centrum Medyczne Lucyna Andrzej Dymek
🇵🇱Strzelce Opolskie, Poland
Queens Hospital
🇬🇧Burton on Trent, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Woolpit Health Centre
🇬🇧Bury St. Edmunds, 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
National Jewish Health
🇺🇸Denver, Colorado, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center
🇺🇸San Jose, California, United States
ENT and Allergy Associates
🇺🇸Newburgh, New York, United States
New Horizons Clinical Research
🇺🇸Cincinatti, Ohio, United States
Allergy and Asthma Clinical Research Inc.
🇺🇸Walnut Creek, California, United States
Greenville Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
Florida Center for Asthma and Allergy Research
🇺🇸Miami, Florida, United States
Pulmonary Consultants of North Idaho
🇺🇸Coeur d'Alene, Idaho, United States
Deaconess Clinic Downtown
🇺🇸Evansville, Indiana, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Pulmonary Associates of Mobile, P.C.
🇺🇸Mobile, Alabama, United States
Colorado Asthma and Allergy Research Centers, P.C.
🇺🇸Centenniel, Colorado, United States
The Brigham and Womens Hospital Inc.
🇺🇸Boston, Massachusetts, United States
Partners in Asthma and Allergy Care, P.A.
🇺🇸Valrico, Florida, United States
North East Medical Research Associates, Inc
🇺🇸North Dartmouth, Massachusetts, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Allergy Associates Research Center
🇺🇸Portland, Oregon, United States
Allergy and Asthma Research Center, P.A.
🇺🇸San Antonio, Texas, United States
Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza
🇭🇺Deszk, Hungary
Johnston Memorial Hospital
🇺🇸Abingdon, Virginia, United States
Szarvasi Tüdőgyógyász Kft.
🇭🇺Szarvas, Hungary
Discovery Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
Men For Care Kft. Százhalom Egészségügyi Központ
🇭🇺Szazhalombatta, Hungary
Vas Megyei Markusovszky Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház
🇭🇺Szombathely, Hungary
Gyógyír XI Kht ( XI Kerületi Tüdőgondozó)
🇭🇺Budapest, Hungary
Margit Kórház
🇭🇺Csorna, Hungary
Prywatny Gabinet Internistyczno - Alergologiczny
🇵🇱Bialystok, Poland
Komárom-Esztergom Megyei Önkormányzat Szent Borbála Kórháza
🇭🇺Tatabánya, Hungary
Érd Városi Önkormányzat Szakorvosi Rendelőintézet
🇭🇺Érd, Hungary
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
IPS Research
🇺🇸Oklahoma City, Oklahoma, United States
Allergy and Asthma Associates/Oak Street Medical P.C.
🇺🇸Eugene, Oregon, United States