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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

December 1, 2008
January 25, 2011
March 2009
February 2010   (final data collection date for primary outcome measure)
Incidence of exacerbation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00801853 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Aerovant
    Aerovant 1mg bid (dry powder)
    Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
  • Drug: Aerovant
    Aerovant 3mg bid (dry powder)
    Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
  • Drug: Aerovant
    Aerovant 10mg bid (dry powder)
    Other Name: AER 001 DPI, BAY 16-9996, pitrakinra
  • Other: placebo
    placebo control (dry powder)
  • Experimental: Aerovant 1
    Aerovant 1mg bid
    Intervention: Drug: Aerovant
  • Experimental: Aerovant 2
    Aerovant 3mg bid
    Intervention: Drug: Aerovant
  • Experimental: Aerovant 3
    Aerovant 10mg bid
    Intervention: Drug: Aerovant
  • Placebo Comparator: Placebo Control
    Placebo Control
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
424
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Hungary,   Poland,   United Kingdom
 
NCT00801853
PPD/2007/AER 001 DPI/2b
No
Babatunde Otulana, M.D., Aerovance, Inc.
Aerovance, Inc.
Not Provided
Principal Investigator: Sally Wenzel, M.D. University of Pittsburgh
Aerovance, Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP