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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801853
• Other study ID #: PPD/2007/AER 001 DPI/2b
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2008
• Last updated: January 25, 2011
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2009
• Source: Aerovance, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

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:

1. Patient has a current diagnosis of respiratory disorder other than asthma (e.g., chronic bronchitis, bronchiectasis, emphysema, chronic obstructive pulmonary disease [COPD], etc).

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Aerovant
Aerovant 1mg bid (dry powder)
• Aerovant
Aerovant 3mg bid (dry powder)
• Aerovant
Aerovant 10mg bid (dry powder)

Other:
• placebo
placebo control (dry powder)

Locations

Country	Name	City	State
Hungary	Dr. Kenessey Albert Kórház - Rendelointézet	Balassagyarmat
Hungary	Gyógyír XI Kht ( XI Kerületi Tüdogondozó)	Budapest
Hungary	Margit Kórház	Csorna
Hungary	Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza	Deszk
Hungary	Érd Városi Önkormányzat Szakorvosi Rendelointézet	Érd
Hungary	Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház	Nyiregyhaza
Hungary	Siofok Varos Korhaz-Rendelointezet	Siofok
Hungary	Szarvasi Tüdogyógyász Kft.	Szarvas
Hungary	Men For Care Kft. Százhalom Egészségügyi Központ	Szazhalombatta
Hungary	Vas Megyei Markusovszky Lajos Általános, Rehabilitációs és Gyógyfürdo Kórház	Szombathely
Hungary	Komárom-Esztergom Megyei Önkormányzat Szent Borbála Kórháza	Tatabánya
Poland	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
United Kingdom	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 States	Johnston Memorial Hospital	Abingdon	Virginia
United States	Allergy and Clinical Immunology	Bangor	Maine
United States	The Brigham and Womens Hospital Inc.	Boston	Massachusetts
United States	Colorado Asthma and Allergy Research Centers, P.C.	Centenniel	Colorado
United States	New Horizons Clinical Research	Cincinatti	Ohio
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Pulmonary Consultants of North Idaho	Coeur d'Alene	Idaho
United States	Asthma and Allergy Associates P.C. and Research Center	Colorado Springs	Colorado
United States	National Jewish Health	Denver	Colorado
United States	Allergy and Asthma Associates/Oak Street Medical P.C.	Eugene	Oregon
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Greenville Pharmaceutical Research	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Allergy and Asthma Specialists Medical Group	Huntington Beach	California
United States	Florida Center for Asthma and Allergy Research	Miami	Florida
United States	Cardiopulmonary Associates of Missoula	Missoula	Montana
United States	Pulmonary Associates of Mobile, P.C.	Mobile	Alabama
United States	ENT and Allergy Associates	Newburgh	New York
United States	North East Medical Research Associates, Inc	North Dartmouth	Massachusetts
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	IPS Research	Oklahoma City	Oklahoma
United States	Asthma and Allergy Research of New Jersey Inc.	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Allergy Associates Research Center	Portland	Oregon
United States	Asthma, Nasal Disease and Allergy Research Center of New England	Providence	Rhode Island
United States	Allergy and Asthma Research Center, P.A.	San Antonio	Texas
United States	Discovery Clinical Trials, LLC	San Antonio	Texas
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 Immunology Associates Ltd	Scottsdale	Arizona
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Pulmonary and Allergy Associates	Summit	New Jersey
United States	Allergy and Asthma Diagnostic Treatment Center	Tallahassee	Florida
United States	Asthma and Allergy Research Associates, PA	Upland	Pennsylvania
United States	Partners in Asthma and Allergy Care, P.A.	Valrico	Florida
United States	Allergy and Asthma Clinical Research Inc.	Walnut Creek	California
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aerovance, Inc.

Countries where clinical trial is conducted

United States,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of exacerbation		4 months	No
Secondary	In-clinic and daily pulmonary function		4 months	No
Secondary	Time to exacerbation after randomization		4 months	No
Secondary	Change from baseline in daily asthma symptom scores		4 months	No
Secondary	Change from baseline in daily beta-agonist reliever use		4 months	No
Secondary	Change from baseline in total IgE		4 months	No
Secondary	Change from baseline in fractional concentration of expired nitric oxide (FENO)		4 months	No
Secondary	Population pharmacokinetics		4 months	No
Secondary	General safety evaluation including lung function, blood pressure, heart rate, respiratory rate, temperature, ECG parameters, safety laboratory tests.		4 months	No
Secondary	SNP analysis for IL-4 and IL-13 relevant genes (Exploratory)		4 months	No

External Links

•   www.aerotrial.com