asthma bronchial MedDRA version: 8.0 Level: llt Classification code 10003555
Conditions
Interventions
Product Name: Formoterol Fumarate Dry Powder Inhaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Formoterol Fumarate
CAS Number: 43229-80-7
Concentration unit: µg microgram(s)
Concentr
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · written informed consent · outpatient of either sex · good health with the exception of asthma · age 18 to 65 years inclusive · history of persistent bronchial asthma (as defined by GINA 2004) for at least 6 months · pretreatment with rescue medication only during the last 4 weeks prior to B0 · FEV1 = 70 % of predicted when measured at least 6 hours after last use of short-acting beta agonists 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
Exclusion criteria
Exclusion criteria: Diseases and health status: · clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation · concomitant severe diseases or diseases which are contraindications for the use of LABAs (e.g. diagnosis or history of significant cardiovascular diseases (amongst others coronary insufficiency, aortic stenosis, hypertrophic myopathy, congestive heart failure, prior myocardial infarction, myocardial impairment, cardiac dysrhythmia), insulin-dependent diabetes mellitus, uncontrolled hypertension, hyperthyroidism, thyrotoxicosis, phaeochromocytoma, hypokalaemia, prolonged QTc interval (male > 430 ms, female > 450 ms), family history of Long QTc syndrome, or tachyarrhythmia) · suffering from COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function · current smoking or cessation of smoking within the last 6 months · previous smoking with a smoking history of = 10 cigarette pack-years · more than one in-patient hospitalization or emergency care visit due to asthma exacerbations in the past year before B0. Medications: · use of inhaled corticosteroids or non-steroidal controller medication within 4 weeks before entry into the baseline period, · use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months · use of other drugs not allowed as defined in the protocol · washout times of drugs defined in the protocol cannot be adhered to · known or suspected hypersensitivity to formoterol or lactose monohydrate · intolerance to salbutamol or to excipients of the MDI · beginning of immunotherapy during the patient´s participation in the study, or having begun an immunotherapy less than 3 months prior to enrolment, or alternation in regimen of an immunotherapy during the study period Common criteria: · pregnancy · intention to become pregnant during the course of the study · breast feeding · lack of safe contraception: lack of safe contraception is defined as follows:Female patients of childbearing potential, not using and not will-ing to continue using a medically reliable method of contracep-tion for the entire study duration, such as oral, injectable, or im-plantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases.· participation in another study within the 30 days preceding and during the present study · previous enrolment into the current study · enrolment of the investigator, his/her family members, employees, and other dependent persons · known or suspected non-compliance, alcohol or drug abuse · inability to follow the procedures of the study, e.g. due to language problems, psychological disorders · reversal of sleep pattern (e.g. night shift workers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of different doses of formoterol fumarate (4.5 µg bid and 9 µg bid) administered by a dry powder inhaler (Ultrahaler™) in comparison to placebo in patients with asthma;Secondary Objective: To study the safety and tolerability of formoterol fumarate administered by a dry powder inhaler;Primary end point(s): Efficacy variables: Primary: · time-averaged AUC 0-12h of FEV1 after 1 week of treatment Secondary: · trough FEV1 · peak FEV1 · proportion of responders as determined from serial FEV1 measurements · time to response as determined from serial FEV1 measurements Safety variables: · AEs · physical examination · vital signs (BP, HR) · ECG · laboratory work-up | — |
Countries
Germany
Outcome results
None listed