| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| moderate persistent to severe persistent asthma |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003553 |
| E.1.2 | Term | Asthma |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenomic sub-study in association with study PPD/2007/AER 001 DPI/2b
The exploratory objective of this study is the following:
Single nucleotide polymorphism (SNP) analysis of genes associated with IL-4 and IL-13 pathways. |
|
| E.3 | Principal 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
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 (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. |
|
| E.4 | Principal 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
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. |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | Yes |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 50 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Last visit of last subject |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
Print
