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A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)

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ClinicalTrials.gov Identifier: NCT00628758
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 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: Symbicort TBH - Turbuhaler
Drug: beta-II-agonist, inhale steroid
Enrollment 430
Recruitment Details FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)
Pre-assignment Details  
Arm/Group Title Symbicort Conventional BP
Hide Arm/Group Description Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) Conventional Best Practice for Treatment of asthma
Period Title: Overall Study
Started 209 221
Completed 165 179
Not Completed 44 42
Reason Not Completed
Adverse Event             2             3
Withdrawal by Subject             6             3
Death             1             0
Protocol Violation             5             1
Lost to Follow-up             25             31
Pregnancy             2             2
Investigator Moved             3             0
Treatment Failure             0             2
Arm/Group Title Symbicort Conventional BP Total
Hide Arm/Group Description Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) Conventional Best Practice for Treatment of asthma Total of all reporting groups
Overall Number of Baseline Participants 209 221 430
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 209 participants 221 participants 430 participants
44.28  (12.09) 45.17  (12.71) 44.7  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants 221 participants 430 participants
Female
157
  75.1%
179
  81.0%
336
  78.1%
Male
52
  24.9%
42
  19.0%
94
  21.9%
1.Primary Outcome
Title Time to First Severe Asthma Exacerbation
Hide Description Time to severe exacerbation among patients
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Conventional Best Practice (BP)
Hide Arm/Group Description:
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microgram (microg), 1 inh bid + as need)
Conventional Best Practice for Treatment of asthma
Overall Number of Participants Analyzed 209 221
Mean (Standard Deviation)
Unit of Measure: days
120.3  (47.0) 103.7  (32.7)
2.Secondary Outcome
Title Number of Severe Asthma Exacerbations
Hide Description Total number of severe asthma exacerbations per treatment group
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Conventional BP
Hide Arm/Group Description:
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional Best Practice for Treatment of asthma
Overall Number of Participants Analyzed 209 221
Measure Type: Number
Unit of Measure: Severe Exacerbations
10 10
3.Secondary Outcome
Title Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Hide Description Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.
Time Frame Baseline and 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis was performed. Being in line with the analysis description population and due to the description of the variable. This patient-reported outcome variable could only be calculated for patients who have baseline and visit 4 AQLQ data. The AQLQ was not filled in by all enrolled patients.
Arm/Group Title Symbicort Conventional BP
Hide Arm/Group Description:
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional Best Practice for Treatment of asthma
Overall Number of Participants Analyzed 146 154
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.98  (1.12) 3.97  (1.15)
4.Secondary Outcome
Title Mean Use of As-needed Medication Per Day During Treatment Period
Hide Description Mean use of as-needed medication per day during treatment period
Time Frame Daily recording during the treatment period of 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis was performed. Being in line with the analysis description population and due to description of the variable which was based on the patient’s estimate, this variable could only be calculated of the patients who had recorded at least one estimate on their dairies they had been asked to return to the investigator at the study visits.
Arm/Group Title Symbicort Conventional BP
Hide Arm/Group Description:
Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional Best Practice for Treatment of asthma
Overall Number of Participants Analyzed 178 193
Mean (Standard Deviation)
Unit of Measure: inhalations per day
0.91  (7.6) 0.68  (5.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Conventional BP
Hide Arm/Group Description Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need) Conventional Best Practice for Treatment of asthma
All-Cause Mortality
Symbicort Conventional BP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Symbicort Conventional BP
Affected / at Risk (%) Affected / at Risk (%)
Total   2/209 (0.96%)   2/221 (0.90%) 
Cardiac disorders     
Cardiac Arrest  1  1/209 (0.48%)  0/221 (0.00%) 
Musculoskeletal and connective tissue disorders     
Lower Limb Fracture  2  0/209 (0.00%)  1/221 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  2  0/209 (0.00%)  1/221 (0.45%) 
Dyspnoea  2  1/209 (0.48%)  0/221 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
2
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort Conventional BP
Affected / at Risk (%) Affected / at Risk (%)
Total   0/209 (0.00%)   0/221 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Phone: +44 1509 645895
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00628758    
Other Study ID Numbers: D5890L00016
First Submitted: January 10, 2008
First Posted: March 5, 2008
Results First Submitted: September 18, 2009
Results First Posted: August 14, 2012
Last Update Posted: August 14, 2012