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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 ug x 2 actuations twice daily (BID)

Budesonide HFA pMDI 160 ug x 2 actuations BID

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 African American population.

A comparison of SYMBICORT® pMDI with budesonide HFA pMDI in African American subjects with asthma.

Research Site

A 52-week, randomised, double-blind, parallel-group, multi-centre, Phase IIIB study comparing the long term safety of SYMBICORT® pMDI 160/4.5 mg x 2 actuations twice daily to budesonide HFA pMDI 160 mg x 2 actuations twice daily in adult/adolescent (≥12 years) African American subjects with asthma

An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.

Age Continuous

Gender, Male/Female

The full analysis set, consisting of all randomized patients who received at least one dose of
randomized study medication and for whom data were collected after randomization.

Total number of asthma exacerbations

Number of participants with at least 1 exacerbation

Asthma exacerbations

QT interval corrected using the Fridericia formula [QTc (Frid)] – Change from baseline to end of treatment

QT interval corrected using the Fridericia formula measured via electrocardiogram (ECG)

Total ectopic ventricular (VE) beats – number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.

Data were available for a subset of patients.

Number of patients with shift from normal to high rate of total ectopic ventricular beats as measured by 24-hour Holter monitor assessment

Total ectopic supraventricular (VE) beats – number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.

Data were available for a subset of patients

Number of patients with shift from normal to high rate of total ectopic supraventricular beats as measured by 24-hour Holter monitor assessment

Total ventricular runs – number of participants with shift normal (<1) to high (≥1) from baseline to week 2.

Total number of ventricular runs as measured by 24-hour Holter monitor assessment

Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered “no” to having used rescue medication that day

Diary Assessments - Rescue-free day

Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered “no” to having symptoms that day

Diary Assessments - Symptom-free day

Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered “no” to having symptoms and “0” to the use of rescue medication that day

Diary Assessments - Asthma-control day

Number of participants with positive response to Item 2 in questionnaire “During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of “strongly agree” or “somewhat agree”

Onset of Effect Questionnaire (OEQ)

Number of participants with positive response to Item 5 in questionnaire “During the past week, you were satisfied with how quickly you felt your study medication begin to work.” The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of “strongly agree” or “somewhat agree”

Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.

Peak Expiratory Flow (PEF) in morning

Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period

Forced Expiratory Volume in one second (FEV1)

Overall score - change from baseline to end of treatment.  For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.

Asthma Treatment Satisfaction Measure (ATSM)

Overall Study

The study included a run-in period of 2 weeks when all patients were prescribed budesonide HFA pMDI 160 μg times 2 actuations BID at individual daily doses and rescue medication, as needed. To be randomized to treatment the patients needed to show pre-dose FEV1 of ≥50%.  One patient in the budesonide group did not receive any dose.

Arms	Assigned Interventions
Experimental: Symbicort Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)	Drug: Budesonide/formoterol (SYMBICORT) pMDI Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Experimental: Budesonide Budesonide HFA pMDI 160 ug x 2 actuations BID	Drug: Budesonide HFA pMDI Budesonide HFA pMDI 160 ug x 2 actuations BID

A comparison of SYMBICORT® pMDI with budesonide HFA pMDI in African American subjects with asthma.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

http://www.asthmaclinicaltrials.com

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=391&filename=CSR-D5896C00022.pdf

CSR-D5896C00022.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator