Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI - ND
- Conditions
- patients with symptomatic asthma on inhaled corticosteroidsMedDRA version: 12.1Level: LLTClassification code 10049106Term: Asthma chronic
- Registration Number
- EUCTR2009-014551-80-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 345
A subject has to meet the following inclusion criteria in order to be eligible for randomisation: 1. Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions. 2. All patients must have a diagnosis of asthma by a physician at least 3 months prior to screening Visit 2. The diagnosis of asthma must be according to the 2008 Global Initiative for Asthma (GINA) Guidelines and must meet the following spirometric criteria: a) Pre-bronchodilator clinic measured FEV1 >= 60% and <= 85% of predicted normal (calculated according to modified NHANES measured >= 6 hours 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 200 ml within 15-30 minutes after administration of 400 micrograms salbutamol HFA MDI. Reversibility testing must be performed during the run-in period at Visit 2 and may be repeated once at Visit 3 if reversibility is not determined at Visit 2. Reversibility testing must not occur on the day of randomisation. 3. The patient must be on at least iCS at a stable dose for at least 3 months prior to screening Visit 2. 4. Diagnosis of asthma must have been made before the age of 40 years. 5. Patient must be symptomatic with an ACQ value of >= 1.5 on the day of randomisation. 6. Male or female patients 18 to 65 years of age inclusive. 7. Body Mass Index (BMI) between 18 >= and <= 35 8. Non-smokers or ex-smokers with a 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 screening visit 2. Pack years = (Number of cigarettes/day x years of smoking)/20 cigarettes/pack. 9. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records (AM2+) during the study period as required in the protocol. 10. Patients must be able to properly use or be trained in the proper use of an MDI.
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 allergic rhinitis) or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following: a) Put the patient at risk because of participation in the study, b) Influence the results of the study, c) Cause concern regarding the patient`s ability to participate in the study. 2.Patients with a clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. Patients will not be randomised if they have an AST, ALT, γGT, TBIL or INR greater than 1.5 fold the upper limit of normal (ULN) at Screening Visit 2. Laboratory testing may be repeated once during the run-in phase. 3. Hospitalisation for asthma exacerbation within 3 months or intubation for asthma within 3 years of screening Visit 2. 4. Patient partially controlled (ACQ6 > 1.5) on iCS plus any other asthma controller therapy (methylxanthines, cromones, LABA, LTRA, including medication wash-out) at Visit 2. 5. Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Screening Visit 2 or during the run-in period. In the case of URTI (without asthma exacerbation) during run-in period, patients can be pre-screened again 4 weeks after the resolution of the infection. 6. Thoracotomy with pulmonary resection. Thoracotomy for other reasons should be assessed under exclusion criterion No. 1. Any of the following safety net criteria are met during the run-in period (from screening to randomisation) a) In clinic FEV1% predicted pre-bronchodilator less than 40%; b) More than 12 puffs rescue salbutamol HFA MDI per day for more than 2 consecutive days; c) Exacerbation of asthma Previous participation in this study (receipt of randomised treatment) or active participation in a current interventional study. 9. Significant alcohol or drug abuse within past 2 years of screening Visit 2. See exclusion criterion No.1. 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 two years. Effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier method of contraception: condom or occlusive cap with spermicidal foam/gel/film/cream/suppository or male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). 12. Patients with known hypersensitivity to any component of the investigational treatment (see Section 4.1.1) or salbutamol or fluticasone propionate MDI or montelukast components. 13.Patients who have been treated with any of the medications in the given interval prior to screening Visit 2 (see protocol section 3.3.2). 14.Patients receiving CYP2C8 substrates such as amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone and repaglinide or CYP2C9 such as warfarin, tolbutamide, phenytoin, losartan and acenocoumarol will be excluded. 15. Patients with a risk for prolonged QT interval
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