Chronic asthma
Conditions
Interventions
Trade Name: Alvesco 160 inhaler
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: Ciclesonide
CAS Number: 141845-82-1
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Hull and East Yorkshire Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients of atleast 18 yrs Patients with history symptomatic asthma (at least 6 months duration) Patients recieveing > 800 mcg but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: patients suffering from any concomitant disease which may interfere with study procedures or evaluation A recent exacerbation of asthma within 8 weeks prior to entry on to study Use of oral glucocorticoids within last 2 months use of rectal, occular, intra articular or other glucocorticosteroids during 4 weeks prior to inclusion. Smoking history >10 pack yrs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of study is to demonstrate that change-over from high dose fluticasone proprionate/salmeterol (500/50 mcg twice daily, given for 4 weeks ) to high dose Ciclesonide /salmeterol (320/50 mcg twice daily, given for 4 weeks) improves adrenal function. Is treatment with ciclesonide superior to fluticasone in terms of adverse effects with respect to adrenal function measured by overnight urinary cortisol:creatinine ratio.;Secondary Objective: The secondary objectives are to demonstrate that ciclesonide/salmeterol (320 mcg/50 mcg, twice daily over 4 weeks) is equivalent to fluticasone/salmeterol (500 mcg/50mcg, ttwice daily over 4 weeks ) in the control of asthmas symptoms in terms of recorded fev1, impulse oscillometry, daily peak flows, daily astma control symptoms, asthma control questionnaire score and use of rescue treatment .;Primary end point(s): Change in overnight urinary cortisol:creatinine ratio from that recorded post 4 weeks fluticasone with that recorded 4 weeks post ciclesonide treatment. | — |
Countries
United Kingdom
Outcome results
None listed