Asthma MedDRA version: 6.1 Level: PT Classification code 10003553
Conditions
Interventions
Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder
CAS Number: 435273-74-8
Current Sponsor code: QAB149
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Male and female adults/adolescents aged 8805; 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 mild to severe persistent asthma, diagnosed according to GINA guidelines Updated 2004 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 200 g BDP or equivalent up to the maximum daily dose as recommended in the package leaflet for at least one month prior to Visit 1. b Patients whose FEV1 at Visit 1 is 8805;50 , of the predicted normal value for the patient. 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 such as albuterol and 48 hours for long acting bronchodilators such as formoterol prior to the evaluation. c Patients who demonstrate a 15 increase in FEV1, over their pre-bronchodilator value within 30 minutes after inhaling a total of 200/180 g salbutamol/albuterol via MDI i.e., two inhalations , demonstrated after an appropriate washout period for all bronchodilators e.g. at least six hours for short-acting bronchodilators such as albuterol and 48 hours for long acting bronchodilators such as formoterol prior to the evaluation. The administration of albuterol for the reversibility test is to be within 30 minutes after a pre bronchodilator spirometry. Reversibility has to be demonstrated either at Visit 1 or between visits 1 and 2, in order for patients to be included in the trial. d Patients experiencing symptoms on a weekly basis as recorded in their diary during the run-in period and having a minimum symptom score of 1 on at least two days per week over the two week run-in period 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
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing lactating women, women of child-bearing potential, UNLESS they are post-menopausal or using an acceptable method of contraception For females aged 12 to 17 years acceptable methods of contraception may include total abstinence at the discretion of the investigator. 2. 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. 3. Patients who suffer from COPD as diagnosed by the GOLD guidelines 2004 . 4. 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. 5. 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 will be permitted to re-enroll at a later date at least 6-weeks after the resolution of the respiratory tract infection . 6. Patients with diabetes Type I or 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. 7. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as but not limited to unstable ischemic heart disease, arrhythmia, 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. 8. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time whether or not there is evidence of local recurrence or metastases . Localized basal cell carcinoma without metastases of the skin is acceptable. 9. Patients with a history of long QT syndrome, or whose QTc interval Bazett s formula measured at Visits 1 or 2 is prolonged 450 ms males; 470 ms females . 10. 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. 12. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer 13. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1 or during the run-in period influenza vaccination is acceptable provided it is not administered within 48 hours prior to Visit 1 or 2 . 14. Patients unable or unwilling to complete a patient daily diary. 15. Treatments for asthma and allied conditions the following medications must not be used prior to Visit 1 for at least the minimum washout period specified below or at any time during the study a The long acting anti-cholinergic agent tiotropium bromide 7 days. b Short acting anti-cholinergics 8 h c Fixed combinations of 61538;2-agonists and inhaled corticosteroids 48 h patients taking fixed dose combination therapy must switch to an equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy d Long-acting 61538;2-agonists other than as prescribed in the study 48 h e Short acting 61538;2-agonists other than
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to provide pivotal confirmation of efficacy and long term safety data for the 200 400 g o.d. doses of indacaterol in persistent asthma. Primary objective s To assess indacaterol s 200 400 g o.d. via Certihaler effectiveness compared to placebo, with respect to 24 h post dose trough FEV1, following 12 weeks of treatment in patients with persistent asthma.;Secondary Objective: Key secondary objective To evaluate the effect of indacaterol 200 400 g o.d. on the percentage of days with no day time symptoms over the first 12 weeks of treatment, compared to placebo. Important secondary objectives To evaluate the effect of indacaterol 200 400 g o.d. on the mean daily number of puffs of rescue medication over 52 weeks of treatment, compared to placebo. To evaluate the effect of indacaterol 200 400 g o.d. on the overall AQLQ S Score after the first12 weeks of treatment, compared to placebo. To evaluate the effect of indacaterol 200 400 g o.d. on the percentage of nights with no night time awakening over 52 weeks of treatment, compared to placebo. Safety To evaluate the long term tolerability and safety of indacaterol 200 400 g o.d. with regard to ECG, laboratory tests, blood pressure, and adverse events as compared with placebo and formoterol, over 52 weeks.;Primary end point(s): Primary objective The primary objective is to determine whether indacaterol 200 g is superior to placebo and whether indacaterol 400 g is superior to placebo with respect to 24 hour post dose trough FEV1 in patients with persistent asthma following 12 weeks of treatment. Primary Variable Trough FEV1 is defined as the average of the 23 h 30 min and the 23 h 55 min values taken in the clinic at Visits 3, 8 and 16 only. At all other visits trough FEV1 is defined as the value taken in the clinic at 5 min prior to dosing. The baseline measurement is the average of the 30 and 5 min pre dose measurements at Visit 2. The prima | — |
Countries
Italy
Outcome results
None listed