A randomized, double-blind, double-dummy, 4-week treatment, parallel-group study to evaluate the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in adult and adolescent patients with persistent asthma

ovartis Pharma Services AG0 个研究点目标入组 616 人开始时间: 2012年4月12日最近更新: 2014年1月27日

适应症

试验速览

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•Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
•- Patients who are receiving ICS treatment
•- Patients whose level of asthma control is Partly Controlled” or Uncontrolled”
•- Patients with a pre-bronchodilator FEV1 value of = 80% of predicted normal value
•- Patients who demonstrate an increase of >- 12% and 200 mL in FEV1
•- Patients who are confirmed as ICS sensitive” by ACQ-5 questionnaire and FEV1.
•*Other protocol defined inclusion criteria may apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 61
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 494
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 61

•- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
•- Patients diagnosed with COPD as defined by the GOLD 2010 guidelines.
•- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
•- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
•*Other protocol-defined exclusion criteria may apply

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