A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort (budesonide/formoterol) HFA pMDI 40/2.25ug twice daily, with and without spacer, in children (6-11 years) with asthma - SPACER
- Conditions
- asthmaMedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2007-002722-29-HU
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
For enrolment in the study patients must fulfil all of the following criteria at Visit 1:
1.Out-patients of either sex, 6 - 11 years
2.Signed Informed Consent from both the patient and the patient’s parent/legal guardian must be obtained prior to any study-related procedures. If the patient cannot read and write, oral consent from the patient is required.
For inclusion in the study run-in period patients must fulfil all of the following criteria at Visit 2:
3.Asthma diagnosed according to the American Thoracic Society (ATS) definition at least 6 months prior to Visit 2.
4.PEF ³ 50 % of predicted normal values (pre-bronchodilator)
5.Daily use of inhaled glucocorticosteroids (GCS of any brand) for =3 months prior to Visit 2
6.During 30 days prior to Visit 2, the dose of any brand of inhaled GCS should have been constant and within the range of 375- 800 µg.
7.Ability to use pMDI, spacer, and peak flow meter correctly
For randomization into the study patients must fulfil all of the following criteria at visit 3:
8.Run-in diary data for mPEF recorded on at least 7 (any 7) of the last 10 days of the run-in period (including the morning of the first day of Visit 3)
9.A mean mPEF during the last 7 days of the run-in period (including the value obtained in the morning of the first day of Visit 3) of 50 to 85% of post-bronchodilatory PEF obtained after administration of inhaled terbutaline sulphate (Bricanyl Turbuhaler; 2 x 0.5 mg/inhalation) at Visit 2 or 3.
10.Total asthma symptom score (night-time plus daytime) of =1 on at least 4 of the last 7 days of the run-in period (not including the recording in the morning of the first day of Visit 3).
11.No change in asthma treatment during the run-in period
12.A successful baseline urine collection, as judged by the investigator, before randomization.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Any of the following is regarded as a criterion for exclusion from the study:
1.Use of oral, parenteral, or rectal GCSs within 30 days prior to Visit 2
2.Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to Visit 2.
3.Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patients ability to participate in the study.
4.Known or suspected hypersensitivity to study therapy or excipents of the investigational products.
5.Current use of any ß2-blocker therapy, including eye-drops.
6.Planned hospitalisation during the study.
7.Any clinically relevant abnormal findings in physical examination, vital signs, or urinalysis at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
8.When applicable, girls of childbearing potential who are not using acceptable contraceptives, as judged by the investigator.
9.Conditions associated with poor compliance.
10.Participation in another clinical study of any investigational drug 30 days prior to or during this study.
11.Previously randomized into the study.
12.Patient’s parent/legal guardian should not be involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to show that Symbicort® pMDI 40/2.25 µg (delivered dose), 4 actuations twice daily (bid) with spacer has a similar systemic steroid potency as Symbicort pMDI 40/2.25 µg, 4 actuations bid in children with asthma. ;Secondary Objective: to compare the clinical efficacy and safety of Symbicort pMDI 40/2.25 µg, 4 actuations bid with or without the spacer in children with asthma.;Primary end point(s): 24-hour Urine Free Cortisol (UFC) excretion
- Secondary Outcome Measures
Name Time Method