EU Clinical Trial Information System (CTIS)

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

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Local phase 4 Pan-European SMART study

Research Site

Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant.  A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Age Continuous

Gender, Male/Female

Treatment with Long-Acting β2 agonist (LABA) at baseline.

Study Specific Characteristic

ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.

Asthma control questionnaire (ACQ5) score at study entry

Exacerbations past 12 months before study start.

Inhaled glucocorticosteroids (IGCS) dose at study entry.

Participants with a well controlled asthma week at study entry.

Peak Expiratory Flow (PEF) was recorded at baseline, the assessment was performed at least 15 minutes after 2 inhalations of Symbicort 160/4.5µg. pn=predicted normal. Symbicort SMART 1*2 arm: n=4001 and Symbicort SMART 2*2 arm: n=4003.

Pulmonary function test at baseline.

Number of severe asthma exacerbations per participant.

The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Fraction of participants with severe asthma exacerbation

A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant

Total number of severe asthma exacerbations that led to hospitalisation and/or emergency room treatment.

Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Total number of days per participant with oral/systemic glucocorticosteroids during severe asthma exacerbation

The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.

Inhalations of as-needed medication recorded by 3880 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3881 participants in the Symbicort SMART 2*2 Reporting Group

Mean daily number of inhalations of as-needed medication.

The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.

Data for this measure recorded by 3714 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3718 participants in the Symbicort SMART 2*2 Reporting Group.

Percent of participants with a well controlled asthma week.

The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.

Data for this measure recorded by 3709 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3735 participants in the Symbicort SMART 2*2 Reporting Group.

Mean Overall Asthma Control Questionnaire (ACQ) Score

The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.

: Data for this measure recorded by 3874 participants in the Symbicort SMART 1*2 Reporting Group and recorded by 3873 participants in the Symbicort SMART 2*2 Reporting Group.

The mean total daily dose of steroids from Symbicort.

Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.

Local phase 4 Pan-European SMART study

Official Title

Medical condition

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Healthy volunteers

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Date

Study design

Verification:

Sponsors

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Inclusion Criteria

Exclusion Criteria

Research Site

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Documents available

http://www.astrazeneca.com/node/emailtriage.aspx

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=384&filename=CSR-D5890L00022.pdf

CSR-D5890L00022.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator