EUCTR2009-012600-48-NL进行中（未招募）不适用
A randomized, partially-blinded, single-dose, 4-way crossover study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol maleate administered via the Concept1 device or as a PulmoSphere® formulation via the Simoon device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female adult patients aged 18-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
- •2. Patients with persistent asthma, diagnosed according to GINA guidelines (National
- •Institute of Health, National Heart, Lung and Blood Institute, 2008) and who additionally meet the following criteria:
- •a. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to screening.
- •b. Patients with an FEV1 at screening of =50% of the predicted normal value for the patient. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a
- •minimum of 48 hours for a long acting ß2-agonist.
- •c. Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value within 10-15 minutes after inhaling a total of 400 µg (4x100µg) of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test). Reversibility will have to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a short-acting ß2-agonist.
- •3. BMI must be within the range 18-32 kg/m2 (inclusive)
- •4. Vital signs (after 3 minutes resting measured in the supine position) not considered by the Investigator to be indicative of a disorder which would make it unsafe for subject to participate in the study or require medical intervention.
- •5. Able to communicate well with the investigator and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •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
排除标准
- •1. Women of child-bearing potential (WOCBP) - for exceptions see protocol
- •2. Male subjects and their partners who are not using two highly effective methods 3. Patients who have had previous intubation for a severe asthma attack/exacerbation.
- •4. Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening.
- •5. Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and Day -1 (Period 1).
- •6. Patients who have had a respiratory tract infection within 6 weeks prior to screening or any time between screening and pre-dose day 1.
- •7. Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
- •8. Patients with a known hypersensitivity to indacaterol or similar drugs.
- •9. Patients who require the use of =8 inhalations per day of the short-acting ß2-agonist (100 µg/90 µg salbutamol/albuterol MDI or equivalent dose of DPI) on any 2 consecutive days from pre-screening.
- •10. Patients diagnosed with COPD as defined by the (GOLD Guidelines 2008).
- •11. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active) or clinically significant bronchiectasis.
- •12. Any patient with lung cancer or a history of lung cancer.
- •13. Participation in any clinical investigation within 4 weeks prior to dosing or longer if
- •required by local regulation. Previous participation in a study with either the
- •investigational or comparator drugs does not exclude a patient from participation in this study.
- •14. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •15. Significant illness within the two weeks prior to dosing.
- •16. History of left-ventricular heart failure or symptomatic coronary atherosclerotic
- •cardiovascular disease (ie, angina, history of MI).
- •17. A past medical history of life-threatening arrhythmias or a history, or family history, of long QT syndrome.
- •18. Patients with a persistent systemic blood pressure = 160/95 mmHg (whether treated or not), measured (in the dominant arm) on 2 separate occasions at least 24-hours apart.
- •19. Pregnant or nursing (lactating) women20. 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% of total Hb measured at screening.
- •21. History of being immunocompromised, including a positive HIV (ELISA and Western blot) test result.
- •22. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •23. Patients who have ever received or are currently receiving treatment with omalizumab will not be allowed to participate in the study.
- •24. Treatments for asthma and allied conditions with listed compounds (see protocol)
研究者
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