Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : Budesonide/Formoterol|Budesonide|Theophylline
INN of investigational material :
Therapeutic category code : 229 Other agents affecting respiratory organ
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. The dose of IGCS must be 400 to 800 ug/day of Pulmicort Turbuhaler or corresponding dose of IGCS. The prescribed dose of IGCS should be constant for at least 4 weeks prior to Visit 1 - Prescribed daily use of sustained release theophylline for at least 8 weeks prior to Visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 ug/mL) during 8 weeks prior to Visit 1. The prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to Visit 1 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 Additional inclusion and exclusion criteria will be evaluated by the Investigator
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy Primary Outcomes: Morning peak expiratory flow (mPEF) Secondary Outcomes: Patient reported outcomes regarding disease status (incl. evening PEF), collected via diaries; Forced expiratory volume in one second (FEV1); Safety:; Adverse events (nature, incidence and severity); Haematology, clinical chemistry and urinalysis; 12-lead ECGs, blood pressure, pulse rate; - all variables assessed over the 8 week treatment period | — |
Outcome results
None listed