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

This study has been completed.
Sponsor:
Information provided by:
Aerovance, Inc.
ClinicalTrials.gov Identifier:
NCT00801853
First received: December 1, 2008
Last updated: January 25, 2011
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Aerovant
Other: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Aerovance, Inc.:

Primary Outcome Measures:
  • Incidence of exacerbation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 424
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerovant 1
Aerovant 1mg bid
Drug: Aerovant
Aerovant 1mg bid (dry powder)
Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
Experimental: Aerovant 2
Aerovant 3mg bid
Drug: Aerovant
Aerovant 3mg bid (dry powder)
Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
Experimental: Aerovant 3
Aerovant 10mg bid
Drug: Aerovant
Aerovant 10mg bid (dry powder)
Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
Placebo Comparator: Placebo Control
Placebo Control
Other: placebo
placebo control (dry powder)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801853

  Show 71 Study Locations
Sponsors and Collaborators
Aerovance, Inc.
Investigators
Principal Investigator: Sally Wenzel, M.D. University of Pittsburgh
  More Information

No publications provided

Responsible Party: Babatunde Otulana, M.D., Aerovance, Inc.
ClinicalTrials.gov Identifier: NCT00801853     History of Changes
Other Study ID Numbers: PPD/2007/AER 001 DPI/2b
Study First Received: December 1, 2008
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Aerovance, Inc.:
asthma
allergy
atopy
atopic
wheeze

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014