moderate persistent to severe persistent asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: AEROVANT
Product Code: AER 001
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Pitrakinra
Current Sponsor code: AER 001
Other descriptive name: BAY 169996
Conce
Sponsors
Aerovance, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 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). Alternatively, the patient has = 10% reversibility from pre-bronchodilator FEV1 plus a documented reversibility of = 12% (and a = 200 mL difference) or documented methacholine or histamine sensitivity (PC20) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 or Theophylline 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 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 AEROVANT™/placebo.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To investigate the effects of AEROVANT™ on the incidence of asthma exacerbations in asthmatic patients treated initially with moderate-to-high doses of ICS and LABA (in the form of combination therapy or as individual therapies in parallel) and not fully controlled on current therapy.;Secondary Objective: Secondary: To examine the effects of AEROVANT™ on daily and in-clinic pulmonary function, time to exacerbation after randomization, daily asthma symptom scores, fractional concentration of expired nitric oxide (FENO), population pharmacokinetics (PK), serum total IgE, and general safety endpoints.;Primary end point(s): The primary efficacy endpoint is exacerbation incidence. Exacerbation is defined by any one of the following: 1. Morning PEF = 30% below baseline for = 2 consecutive days AND = 6 additional reliever occasions (1 puff = 1 reliever occasion) in a 24-hour period over baseline for = 2 consecutive days, OR 2. Deterioration of asthma requiring treatment with oral corticosteroids, OR 3. Deterioration of asthma requiring treatment increase = 4 times the baseline dose of inhaled corticosteroids, OR 4. Deterioration of asthma requiring hospitalization, OR 5. In the opinion of the Investigator, the patient’s condition is deteriorating significantly to the point of considering it an asthma exacerbation. | — |
Countries
Hungary, Poland, United Kingdom
Outcome results
None listed