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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

Budesonide/formoterol pMDI 40/2.25ug + spacer

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Evaluation of safety and efficacy of Symbicort® pMDI, with or without spacer, in children (6-11 years) with asthma

Research Site

A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort®  (budesonide/formoterol) HFA pMDI 40/2.25 μg twice daily, with and without spacer, in children (6-11 years) with asthma

Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment

Age Continuous

Gender, Male/Female

Urinary Free Cortisol (UFC)

Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.

Forced Expiratory Volume in 1 Second (FEV1)

Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.

Morning Peak Expiratory Flow (mPEF)

Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.

Evening Peak Expiratory Flow (ePEF)

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 =  Severe symptoms.

Asthma Symptoms at Night

Asthma Symptoms at Day

Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.

Percentage of Nights With Awakenings Due to Asthma

Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.

Arms	Assigned Interventions
Experimental: With Spacer Budesonide/formoterol pMDI 40/2.25ug + spacer	-
Experimental: Without Spacer Budesonide/formoterol pMDI 40/2.25 ug	-

Evaluation of safety and efficacy of Symbicort® pMDI, with or without spacer, in children (6-11 years) with asthma - Spacer

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=393&filename=CSR-D5897C00004.pdf

CSR-D5897C00004.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator