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Clinical Trials/EUCTR2007-006545-41-PL
EUCTR2007-006545-41-PLActive, not recruitingNot Applicable

A PHASE IIB STUDY TO INVESTIGATE THE TREATMENT-SPARING EFFECTS OFAEROVANT™ (AER 001 INHALATION POWDER) IN ASTHMA PATIENTS NOT FULLYCONTROLLED ON CURRENT THERAPY - AEROVANT

Aerovance, inc0 sites500 target enrollmentStarted: February 24, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
500
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •In order to be eligible for the study each of the following criteria must be satisfied with a
  • •YES” answer:
  • •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 four times the baseline dose of inhaled corticosteroids or hospitalization for 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). Alternatively, the patient has = 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of = 12% within the previous 12 months (Documented methacholine or histamine sensitivity (PC20) less than 8 mg/mL is also acceptable evidence of reversible airways disease).
  • •7) Patient scores = 20 on The Asthma Control Test™ at Screening (Visit 1) and
  • •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 (see Section 4.7.2). 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •In order to be eligible for this study, each of the following criteria must be satisfied with a NO” answer:
  • •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 as defined in Section 4.7.2 (of the protocol).
  • •5) Patient has a clinically relevant history of very severe asthma or other medical history 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
  • •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.

Investigators

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