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Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma (Spacer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00536913
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : February 27, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
Drug: Budesonide/formoterol pMDI 40/2.25 ug
Enrollment 107
Recruitment Details 137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised
Pre-assignment Details  
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description Budesonide/formoterol pMDI 40/2.25ug + spacer Budesonide/formoterol pMDI 40/2.25 ug
Period Title: Overall Study
Started 55 52
Completed 55 52
Not Completed 0 0
Arm/Group Title With Spacer Without Spacer Total
Hide Arm/Group Description Budesonide/formoterol pMDI 40/2.25ug + spacer Budesonide/formoterol pMDI 40/2.25 ug Total of all reporting groups
Overall Number of Baseline Participants 55 52 107
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 55 participants 52 participants 107 participants
8.6
(6 to 11)
8.9
(6 to 11)
8.7
(6 to 11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 52 participants 107 participants
Female
21
  38.2%
22
  42.3%
43
  40.2%
Male
34
  61.8%
30
  57.7%
64
  59.8%
1.Primary Outcome
Title Urinary Free Cortisol (UFC)
Hide Description 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
Time Frame At baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 54 51
Geometric Mean (Full Range)
Unit of Measure: Ratio
0.86
(0.20 to 2.4)
1.03
(0.12 to 5.4)
2.Secondary Outcome
Title Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.
Time Frame At baseline, at 2 weeks and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Full Range)
Unit of Measure: Liters
0.17
(-0.38 to 0.76)
0.14
(-0.34 to 0.82)
3.Secondary Outcome
Title Morning Peak Expiratory Flow (mPEF)
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Liters/min
28.70  (24.6) 19.50  (25.1)
4.Secondary Outcome
Title Evening Peak Expiratory Flow (ePEF)
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Liters/min
27.00  (27.7) 15.30  (23.0)
5.Secondary Outcome
Title Asthma Symptoms at Night
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.20  (0.46) -0.21  (0.39)
6.Secondary Outcome
Title Asthma Symptoms at Day
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.25  (0.43) -0.28  (0.41)
7.Secondary Outcome
Title Percentage of Nights With Awakenings Due to Asthma
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Percentage of nights
-13.80  (27.2) -8.20  (23.8)
8.Secondary Outcome
Title Use of Rescue Medication at Night
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Inhalations
-0.21  (0.50) -0.14  (0.38)
9.Secondary Outcome
Title Use of Rescue Medication at Day
Hide Description 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.
Time Frame Daily during run-in and daily during treatment period of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description:
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: Inhalations
-0.30  (0.56) -0.19  (0.41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title With Spacer Without Spacer
Hide Arm/Group Description Budesonide/formoterol pMDI 40/2.25ug + spacer Budesonide/formoterol pMDI 40/2.25 ug
All-Cause Mortality
With Spacer Without Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
With Spacer Without Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/52 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
With Spacer Without Spacer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/52 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00536913    
Other Study ID Numbers: D5897C00004
First Submitted: September 26, 2007
First Posted: September 28, 2007
Results First Submitted: February 16, 2009
Results First Posted: February 27, 2012
Last Update Posted: April 6, 2012