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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

To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Phase4/Symbicort® versus Pulmicort Flexhaler® in African Americans

160/4.5 μg x 2 actuations twice daily (bid)

inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Research Site

A 12-wk, rand., double-blind, double dummy, multi-ctr., phase IV study comparing efficacy and safety of SYMBICORT® pMDI 160/4.5 ug x 2 actuations twice daily versus Pulmicort® (budesonide inhalation powder DPI) 180 ug x 2 inhalations twice daily, in adult and adolescent African American subjects with asthma

Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Age Continuous

Gender, Male/Female

Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.

Change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) averaged over treatment period

Change from baseline in morning peak expiratory flow (AM PEF) averaged over the treatment period

Change from baseline in evening peak expiratory flow (PM PEF) averaged over the treatment period

Change from baseline in pre-dose forced vital capacity (FVC) averaged over the treatment period

Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.

Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period

Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)

Number of first predefined asthma events by inhaled corticosteroid (ICS) dose at entry

Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)

Number of withdrawals due to a predefined asthma event

Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period

Change from baseline in total average daily asthma symptom score averaged over the treatment period

Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)

Change from baseline in nighttime asthma symptom score averaged over the treatment period

Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)

Change from baseline in daytime asthma symptom score averaged over the treatment period

Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline in awakening-free nights averaged over the treatment period

Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to the average in total rescue medication use averaged over the treatment period

Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to the average in nighttime rescue medication use averaged over the treatment period

Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to the average in daytime medication use averaged over the treatment period

Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to the average in rescue medication-free days averaged over the treatment period

Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline in asthma symptom-free days averaged over the treatment period

Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to the average for asthma-control days averaged over the treatment period

12 years and older

18 years and older

Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away

Perception of onset of medication effect at last week of treatment assessed by number of participants who agreed with Item 2 on the Onset of Effect Questionnaire (OEQ)

Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Change from baseline to end of treatment in overall score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S])

There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5).  To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.

Proportion of participants who reported on the Asthma Control Test (ACT) that their asthma was controlled at the last week of treatment

There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.

Change from baseline to last week of treatment in scores on the Asthma Impact Survey (AIS)

Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.

Perception of onset of medication effect at last week of treatment assessed by number of participants who agreed with Item 5 on the Onset of Effect Questionnaire (OEQ)

Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away

Perception of onset of medication effect at first week of treatment assessed by number of participants who agreed with Item 2 on the Onset of Effect Questionnaire (OEQ)

Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.

Perception of onset of medication effect at first week of treatment assessed by number of participants who agreed with Item 5 on the Onset of Effect Questionnaire (OEQ)

Overall Study

10 subjects were excluded from the FAS: 9 who received the incorrect study medication and 1 who was randomized to receive SYMBICORT pMDI, but never received study medication.
Therefore, 153 subjects (from 156 randomized to Symbicort) and 148 (from 155 randomized to Budesonide) were included in the FAS used to present baseline characteristics.

Arms	Assigned Interventions
Experimental: 1	Drug: Budesonide / formoterol fumarate (SYMBICORT) 160/4.5 μg x 2 actuations twice daily (bid) Other Name: SYMBICORT
Active Comparator: 2	Drug: Budesonide inhalation powder 180 μg x 2 inhalations bid (PULMICORT) Other Name: PULMICORT

Phase4/Symbicort® versus Pulmicort Flexhaler® in African Americans - Titan

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

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Sponsors

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=394&filename=CSR-D589BL00003.pdf

CSR-D589BL00003.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator