Estudio multicéntrico, aleatorizado, doble ciego, doble enmascarado, con grupos paralelos de 26 semanas de tratamiento, para evaluar la seguridad de indacaterol (300 y 600 µg o.d.) en pacientes con asma moderada-grave persistente que utilizan salmeterol (50 µg b.i.d.) como control activo.
- Conditions
- asma persistente moderada severaMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2007-001005-16-ES
- Lead Sponsor
- ovartis Farmacéutica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
1.Male and female adults/adolescents aged = 12 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. In the case of patients below the legal age of consent, the Informed Consent Form must also be signed by the patient’s parent / guardian.
2.Patients with moderate to severe persistent asthma, diagnosed according to GINA guidelines (Updated 2006) and who additionally meet the following criteria:
a)Patients who have used treatment with a bronchodilator, either regularly or on-demand, and who have used a daily dose of at least 100 µg BDP (HFA) or equivalent (up to the maximum daily dose as recommended in the package leaflet) for at least one month prior to Visit 1. In addition patients must have been taking a stable dose for at least one month prior to Visit 1.
b)Patients whose FEV1 is =50% of the predicted normal value for the patient at both Visit 1 and Visit 2. This criterion for FEV1 is to be demonstrated after an appropriate washout period for all bronchodilators (e.g. at least six hours for short-acting bronchodilators and 48 hours for long acting bronchodilators and formoterol) prior to the evaluation.
c)Patients with documented (in the previous 6 months) or who demonstrate (prior to visit 2) a =12% and at least 200 ml increase in FEV1, over their pre-bronchodilator value within 30 minutes after inhaling a total of 200/180 µg salbutamol/albuterol (i.e. two inhalations), demonstrated after an appropriate washout period for all bronchodilators prior to the evaluation.
Are the trial subjects under 18? yes
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
-Pregnant or nursing (lactating) women
-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m OR are using one or more of the following acceptable methods of contraception(surgical sterilization, hormonal contraception, double-barrier methods). For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation
-Patients who have used tobacco products within the 12 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years
-Patients who suffer from COPD as diagnosed by the GOLD guidelines (2006).
-Patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to Visit 1 or who have been hospitalized for an acute asthma attack in the 6 months prior to Visit 1, or at any time between Visit 1 and Visit 2.
-Patients who have had a respiratory tract infection within 6-weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and 2 must discontinue from the trial, but may be permitted to re-enroll at a later date
-Patients with diabetes Type I or those with uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1C >8.0% measured at Visit 1.
-Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable atrial fibrillation), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state, that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
-Any patient with active cancer or a history of cancer with less than 5 years disease free survival time. Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients with a history of cancer and 5 years or more disease free survival time may be included in the study by agreement with Novartis H.Q.personnel on a case-by-case basis.
-Patients with a history of long QT syndrome, or whose QTc interval is prolonged to > 450 ms (males) or > 470 ms (females).
-Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
-Patients who do not maintain regular day/night, waking/sleeping cycles
-Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 or during the run-in period.
-Patients with a known history of non-compliance to medication or who are unable or unwilling to complete a patient daily diary.
-Treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method