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AsthmaPhase 2NCT00801853

A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL

A Phase 2 study testing Aerovant in people with Asthma, run by Aerovance, Inc. at 71 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Aerovant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
424 participants
Where
71 sitesin 4 countries
Study dates
Mar 2009to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

71 sites in 4 countries.

71 sites in 4 countries

United States38 sites

  • Johnston Memorial Hospital

    Abingdon, Virginia

  • Allergy and Clinical Immunology

    Bangor, Maine

  • The Brigham and Womens Hospital Inc.

    Boston, Massachusetts

  • Colorado Asthma and Allergy Research Centers, P.C.

    Centenniel, Colorado

  • Bernstein Clinical Research Center

    Cincinnati, Ohio

  • New Horizons Clinical Research

    Cincinnati, Ohio

  • Pulmonary Consultants of North Idaho

    Coeur d'Alene, Idaho

  • Asthma and Allergy Associates P.C. and Research Center

    Colorado Springs, Colorado

  • National Jewish Health

    Denver, Colorado

  • Allergy and Asthma Associates/Oak Street Medical P.C.

    Eugene, Oregon

  • Deaconess Clinic Downtown

    Evansville, Indiana

  • Greenville Pharmaceutical Research

    Greenville, South Carolina

  • Baylor College of Medicine

    Houston, Texas

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California

  • Florida Center for Asthma and Allergy Research

    Miami, Florida

  • Cardiopulmonary Associates of Missoula

    Missoula, Montana

  • Pulmonary Associates of Mobile, P.C.

    Mobile, Alabama

  • ENT and Allergy Associates

    Newburgh, New York

  • North East Medical Research Associates, Inc

    North Dartmouth, Massachusetts

  • Allergy, Asthma and Clinical Research Center

    Oklahoma City, Oklahoma

  • IPS Research

    Oklahoma City, Oklahoma

  • Asthma and Allergy Research of New Jersey Inc.

    Philadelphia, Pennsylvania

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Allergy Associates Research Center

    Portland, Oregon

  • Asthma, Nasal Disease and Allergy Research Center of New England

    Providence, Rhode Island

  • Allergy and Asthma Research Center, P.A.

    San Antonio, Texas

  • Discovery Clinical Trials, LLC

    San Antonio, Texas

  • Allergy Associates Medical Group Inc.

    San Diego, California

  • Institute of Healthcare Assessment Inc.

    San Diego, California

  • Allergy and Asthma Associates of Santa Clara Valley Research Center

    San Jose, California

  • Allergy and Immunology Associates Ltd

    Scottsdale, Arizona

  • Spartanburg Medical Research

    Spartanburg, South Carolina

  • Pulmonary and Allergy Associates

    Summit, New Jersey

  • Allergy and Asthma Diagnostic Treatment Center

    Tallahassee, Florida

  • Asthma and Allergy Research Associates, PA

    Upland, Pennsylvania

  • Partners in Asthma and Allergy Care, P.A.

    Valrico, Florida

  • Allergy and Asthma Clinical Research Inc.

    Walnut Creek, California

  • Wake Forest University

    Winston-Salem, North Carolina

Other trials in United States

United Kingdom12 sites

  • Barnsley District Hospital

    Barnsley

  • Birmingham Heartlands Hospital

    Birmingham

  • Queens Hospital

    Burton-on-Trent

  • Woolpit Health Centre

    Bury St Edmunds

  • Addenbrookes Hospital

    Cambridge

  • Avondale Surgery

    Chesterfield

  • Chesterfield Royal Hospital

    Chesterfield

  • Colchester General Hospital

    Colchester

  • Gartnavel General Hospital

    Glasgow

  • Glenfield Hospital

    Leicester

  • Hammersmith Hospital

    London

  • Morriston Hospital

    Swansea

Other trials in United Kingdom

Hungary11 sites

  • Dr. Kenessey Albert Kórház - Rendelőintézet

    Balassagyarmat

  • Gyógyír XI Kht ( XI Kerületi Tüdőgondozó)

    Budapest

  • Margit Kórház

    Csorna

  • Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza

    Deszk

  • Érd Városi Önkormányzat Szakorvosi Rendelőintézet

    Érd

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

    Nyíregyháza

  • Siofok Varos Korhaz-Rendelointezet

    Siófok

  • Szarvasi Tüdőgyógyász Kft.

    Szarvas

  • Men For Care Kft. Százhalom Egészségügyi Központ

    Százhalombatta

  • Vas Megyei Markusovszky Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház

    Szombathely

  • Komárom-Esztergom Megyei Önkormányzat Szent Borbála Kórháza

    Tatabánya

Other trials in Hungary

Poland10 sites

  • Prywatny Gabinet Internistyczno - Alergologiczny

    Bialystok

  • 10 Wojskowy Szpital Kliniczny z Poliklinika Kliniczny Oddzial Pulmonologiczny

    Bydgoszcz

  • Specjalistyczny Zespol Chorob Pluc i Gruzlicy w Bystrej

    Bystra

  • Medcare NZOZ

    Gdansk

  • All-Med

    Krakow

  • NZOZ Centrum Alergologii prof. Krzysztof Buczylko

    Lodz

  • Poradnia Alergologii i Chorob Pluc SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlicki

    Lodz

  • AlergoTest SC

    Lublin

  • NZOZ Centrum Medyczne Lucyna Andrzej Dymek

    Strzelce Opolskie

  • Alergomed Specjalistyczna Przychodnia Lekarska sp zoo

    Tarnów

Other trials in Poland

About this study

Official title: 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

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.

Conditions
Asthma
Being tested
Aerovant, placebo
Keywords
asthma, allergy, atopy, atopic, wheeze
Medical subject headings
Asthma, Hypersensitivity, Respiratory Sounds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AerovantDrug

    Also called AER 001 DPI, BAY 16-9996, pitrakinra

    Aerovant 1mg bid (dry powder)

  • AerovantDrug

    Also called AER 001 DPI, BAY 16-9996, pitrakinra

    Aerovant 3mg bid (dry powder)

  • AerovantDrug

    Also called AER 001 DPI, BAY 16-9996, pitrakinra

    Aerovant 10mg bid (dry powder)

  • placeboOther

    placebo control (dry powder)

Study groups in NCT00801853
Study groupRoleWhat they receive
Aerovant 1ExperimentalAerovant 1mg bid
Receives: Drug: Aerovant
Aerovant 2ExperimentalAerovant 3mg bid
Receives: Drug: Aerovant
Aerovant 3ExperimentalAerovant 10mg bid
Receives: Drug: Aerovant
Placebo ControlPlacebo comparatorPlacebo Control
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of exacerbation

    Measured: 4 months

Secondary outcomes (9)

  1. In-clinic and daily pulmonary function

    Measured: 4 months

  2. Time to exacerbation after randomization

    Measured: 4 months

  3. Change from baseline in daily asthma symptom scores

    Measured: 4 months

  4. Change from baseline in daily beta-agonist reliever use

    Measured: 4 months

  5. Change from baseline in total IgE

    Measured: 4 months

  6. Change from baseline in fractional concentration of expired nitric oxide (FENO)

    Measured: 4 months

  7. Population pharmacokinetics

    Measured: 4 months

  8. General safety evaluation including lung function, blood pressure, heart rate, respiratory rate, temperature, ECG parameters, safety laboratory tests.

    Measured: 4 months

  9. SNP analysis for IL-4 and IL-13 relevant genes (Exploratory)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2008 (estimated)
  2. Study startMar 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00801853
Sponsor's protocol ID
PPD/2007/AER 001 DPI/2b
Status last verified
Nov 2009
First submitted
1 Dec 2008
Last updated
27 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22541248

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aerovant in people with Asthma, run by Aerovance, Inc. at 71 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, United Kingdom, Hungary, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of exacerbation (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00801853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.

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