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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily

budesonide HFA pMDI 160 μg x 2 actuations twice daily

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

An efficacy study comparing SYMBICORT® pressurised Metered Dose Inhaler (pMDI) with budesonide hydrofluoroalkanes (HFA) pMDI, in Hispanic subjects with ICS dependent asthma

Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Research Site

A 12-week, randomised, double blind, active-controlled, multi-centre, phase IIIB study comparing the efficacy and safety of SYMBICORT® pMDI 160/4.5 mg x 2 actuations twice daily versus budesonide HFA pMDI 160 mg x 2 actuations twice daily, in adult/adolescent (> 12 yrs) Hispanic subjects with asthma

Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the  treatment period of 12 weeks, with baseline value as covariate.

Asthma Events, defined as any of: decrease in lung function (FEV1 or  AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring  use of rescue medication, exacerbation of asthma requiring medical assistance,  use of not allowed asthma medication

Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Change from baseline (average of daily records over the 14 days of run-in)  to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate. 

Daily scale:
- 0 = No symptoms
- 1 = Mild symptoms
- 2 = Moderate symptoms 
- 3 =  Severe symptoms

Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate. 

Daily scale:
- 0 = No symptoms
- 1 = Mild symptoms 
- 2 = Moderate symptoms 
- 3 =  Severe symptoms

Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.

Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.

The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse  transformed to a binary variable with points 1 and 2 combined as “Yes” and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.

The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse  transformed to a binary variable with points 1and 2 combined as “Yes” and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.

Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the
highest level of satisfaction and 0 the lowest level of satisfaction.

Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated  for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the
highest level of satisfaction and 0 the lowest level of satisfaction.

Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated  for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the
highest level of satisfaction and 0 the lowest level of satisfaction.

Arms	Assigned Interventions
Active Comparator: Symbicort SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily	Drug: Budesonide/formoterol (SYMBICORT) pMDI SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Active Comparator: Budesonide budesonide HFA pMDI 160 μg x 2 actuations twice daily	Drug: Budesonide HFA pMDI Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

An efficacy study comparing SYMBICORT® pressurised Metered Dose Inhaler (pMDI) with budesonide hydrofluoroalkanes (HFA) pMDI, in Hispanic subjects with ICS dependent asthma

Official Title

Medical condition

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Healthy volunteers

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Documents available

http://www.asthmaclinicaltrials.com

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=538&filename=CSR-D5896C00021.pdf

CSR-D5896C00021.pdf

Trial Results Summaries

Contacts

Contact

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Investigators

Principal Investigator