Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : Budesonide/Formoterol
INN of investigational material :
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and Administrat
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 16 Years and above Genders Eligible for Study: Both Criteria Inclusion Criteria: - Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1 - Prescribed daily use of an IGCS for =12 weeks prior to Visit 1 - Prescribed daily use of at least one of the following: Theophylline, long acting beta2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose Exclusion Criteria: - Any significant disease or disorder that may jeopardize the safety of the patient - Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1 - Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy Primary Outcomes: Safety: Adverse events (nature, incidence and severity), Haematology, clinical chemistry, morning plasma cortisol, urinalysis, and ACTH challenge test 12-lead ECGs, blood pressure, pulse rate Secondary Outcomes: Patient reported outcomes regarding disease status (incl. PEF), collected via diaries; Forced expiratory volume in one second (FEV1); - all variables assessed over the 52 week treatment period | — |
Outcome results
None listed