Randomised, double-blind, double-dummy, placebo-controlled,parallel group study to assess the efficacy and safety of 6 weeksof oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., orplacebo in symptomatic asthma patients on fluticasonepropionate MDI
- Conditions
- Symptomatic asthmatic patients on inhaled corticosteroidsMedDRA version: 12.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2009-014551-80-SE
- Lead Sponsor
- Boehringer Ingelheim AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. Signed informed consent prior to any study procedures, which includes medication washout and restrictions. 2. Diagnosis of asthma by a physician at least 3 months prior to Visit2. The diagnosis must be according to the 2008 GINA Guidelines and must meet the following spirometric criteria: a) Pre-bronchodilator clinic measured FEV1=60% and =85% predicted normal (modified NHANES measured =6hours after the last use of salbutamol/albuterol rescue medication on the day of randomisation.b) FEV1 reversibility: Improvement in FEV1=12% above baseline and an absolute change of at least 200ml within 15-30 minutes after 400µg salbutamol HFA MDI. Reversibility testing must be performed during the run-in at Visit2 and may be repeated once at Visit3. It must not occur on the day of randomisation.
3. Patient must be on at least iCS at a stable dose for at least 3 months and at a stable dose for at least 6 weeks prior to screening Visit2. 4. Diagnosis of asthma made before the age of 40 years. 5. Patient must be symptomatic with an ACQ=1.5 on the day of randomisation. 6. Male or female patients 18 to 65 yrs of age inclusive. 7. BMI between 18=and=35. 8. Non-smokers or ex-smokers with cigarette smoking history of = 10 pack-years (and smoking cessation for at least one year prior to enrolment). Patients must have a negative urinary cotinine at visit 2. 9. Able to perform technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records (AM2+®).
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) no
F.1.3.1 Number of subjects for this age range
1. Significant pulmonary disease other than asthma or other medical conditions that may put the patient at risk, influence the results of the study, cause concern regarding the patient’s ability to participate in the study. Patients with malignancy for which patient has undergone resection/radiation/chemotherapy within past 5yrs. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed. 2. Clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease. Patients with AST, ALT, ?GT, TBIL or INR>1.5 ULN at Visit2. 3. Hospitalisation for asthma exacerb. within 3mths or intubation for asthma within 3yrs of Visit2. 4. Partially controlled (ACQ6>1.5) on iCS plus any other asthma controller at Visit2. 5. Respiratory tract infection or asthma exacerb. in the 4wks prior to Visit2 or during the run-in. In case of URTI (without asthma exacerb.) during run-in, patients can be pre-screened again 4wks after resolution. 6. Thoracotomy with pulmonary resection. Thoracotomy for other reasons should be assessed (excl.1). 7. Any safety net criteria are met during the run-in period a) In clinic FEV1 %predicted pre-bronchodilator <40%, b) >12 puffs rescue salbutamol HFA MDI per day for>2 consecutive days, c) Exacerbation of asthma. If AM2+ indicates a drop in absolute PEF of 30% from average absolute PEF of the last pre-screening week or last week prior to Visit4, for>2 consecutive days, an alert is generated, the patient should contact the study site for immediate assessment. 8. Previous participation in this study or participation in a current interventional study. 9. Significant alcohol or drug abuse within past 2yrs of Visit2. 10. Pregnant or nursing women. 11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2yrs. Effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an IUD or IUS, barrier method of contraception: condom or occlusive cap with spermicidal foam/gel/film/ cream/suppository or male sterilization (with appropriate post-vasectomy document of the absence of sperm in the ejaculate). 12. Known hypersensitivity to any component of the investigat. treatment, salbutamol, fluticasone or montelukast components. 13. Patients who have been treated with any of the following medications in the given interval prior to Visit2: a) An investigational drug within 1mth or 6 1/2 lives (whichever is greater). b) Started on immunotherapy <1yr prior to Visit2. Patient should on the same course of immunotherapy for at least 1yr to be admitted into the study. Adjustment in dose within 1yr is allowed, as long as it involves the same course of immunotherapy and they have been on that dose for at least 6mths prior to Visit2. c)A biological based antagonist therapy including Omalizumab or immune modulator within 6mths. d)A systemic (i.v., i.m. or oral)corticosteroid within 3mths. e) A long acting anticholinergic bronchodilator within 2wks. f) Any of the following bronchodilators within 24hrs: inhaled anticholinergic agents, including fixed dose anticholinergic/ß2adrenergics, LABA including combination iCS/LABA, methylxanthines and ora
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