A randomized, double blind, placebo and active controlled, parallel groupstudy to evaluate the safety and efficacy of 6-week treatment with oral doses of50 mg b.i.d., 200 mg b.i.d., and 400 mg b.i.d. BI 671800 ED in steroid-naïvepatients with persistent asthma
- Conditions
- Mild asthma
- Registration Number
- EUCTR2010-023326-20-LV
- Lead Sponsor
- Boehringer Ingelheim RCV GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
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. The Diagnosis of Asthma must be according to the 2008 Global Initiative for Asthma (GINA) Guidelines (P09-00393) and must meet both of the following spirometric criteria:
a)Pre-bronchodilator clinic measured FEV1 =60% and =85% of predicted normal (calculated by modified NHANES [R04-1001]) measured =6 hours after the last use of short acting bronchodilator (see Section 5.1.1) on the day of screening and randomisation.
b)FEV1 reversibility: Improvement in FEV1 =12% above baseline and an absolute change of at least 200 ml within 15 minutes after administration of 400 µg salbutamol. Reversibility testing must be performed during the screening / run-in period and may be repeated if reversibility is not determined in the first test. Reversibility testing must not occur on the day of randomisation.
3.The patient must not be taking asthma controller therapy for at least 3 months prior to screening Visit 2. The patient may be receiving a bronchodilator prn.
4.Diagnosis of asthma must have been made before the age of 40 years.
5.Patient must be symptomatic with an ACQ (R00-1157) 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.Patients must be non-smokers or ex-smokers, having stopped smoking at least 1 year prior to Screening Visit 2 and with a smoking history of <10-pack years. Patients must have a negative urinary cotinine test at Screening Visit 2.
Pack Years =
Number of cigarettes / day
20x years of smoking
Patients who are currently smoking cigarettes must be excluded
9.Patients must be able to perform technically acceptable pulmonary function tests and electronic PEF measurements, and must be able to maintain records (Patient Daily Diary) 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 a metered dose inhaler (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 the 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.
3.Hospitalisation for asthma exacerbation within 3 months or intubation for asthma within 3 years of Screening Visit 2.
4.Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Screening Visit 2 or during the run in period.
5.Thoracotomy with pulmonary resection. Thoracotomy for other reasons should be assessed under Exclusion No. 1
6.Any of the following safety net criteria are met during the run in period (from Screening Visit 2 to Randomisation Visit d.Drop in FEV1 % predicted pre-bronchodilator to below 40%e.More than 12 puffs of a short-acting ?2-adrenergic agonist (SABA) per day for more than 2 consecutive days f.Exacerbation (as defined in Section 5.1)
7.Previous participation in this study (receipt of randomized treatment) or active participation in a current interventional study.
8.Significant alcohol or drug abuse within past 2 years. See exclusion criteria No.1.
9.Pregnant or nursing women.
10.Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
11.Patients with known hypersensitivity to any component of the investigational treatment (see Section 4.1.1) or to the albuterol/salbutamol or fluticasone MDI components.
12.Patients who have been treated with any of the following medications in the given interval prior to Screening Visit 2:
a.An investigational drug within 1 month or six half lives (whichever is greater)
b.Patients who were started on immunotherapy less than one year prior to Visit 2. The patient should on the same course of immunotherapy for at least one year to be admitted into the study. A patient will be allowed an adjustment in dose within one year as long as it involves the same course of immunotherapy and they have been on that dose for at least 6 months prior to Visit 2
c.A biological based antagonist therapy including Omalizumab, or immune modulator within 6 months of Visit 2
d.A systemic (intravenous, intramuscular, or oral) corticosteroid within 3 months of Visit 2
e.A long acting anticholinergic bronchodilator within two weeks of Visit 2
f.Any of the following bronchodilators from 24 hours prior to screening Visit 2 to randomisation: short acting inhaled anticholinergic agents including fixed dose anticholinergic/ beta agonist combinations, long acting inhaled beta agonists
g.The following anti-allergy medications within 2 weeks: topical nasal steroid, oral antihistamines, oral decongestants. Topical antihistamines and topical decongestants are permitted on an as needed basis for symptoms of allergic rhino-conjunctivitis
h.A non-steroidal anti-inflammatory medication including aspirin and COX-2 inhibitors within 1 week
i.Non-cardio-selective beta-blocker medications (e.g., propranolol) within 2 weeks. Topical beta blocker eye medications are allowed
j.Any of the follo
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