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Trial record 22 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

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ClinicalTrials.gov Identifier: NCT00419757
Recruitment Status : Completed
First Posted : January 9, 2007
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Budesonide/formoterol (SYMBICORT) pMDI
Drug: Budesonide HFA pMDI
Enrollment 558
Recruitment Details 39 centres in United States enrolled 558 patients with asthma into this study. 308 patients were excluded: 279 for incorrect enrollment/eligibility criteria not fulfilled, 14 for voluntary discontinuations, 2 for development of study specific discontinuation criteria, 2 for adverse events, 10 were lost to follow-up
Pre-assignment Details Male or female, Hispanic (self-reported), ≥12 years
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Period Title: Overall Study
Started 127 [1] 123 [1]
Completed 109 [1] 102 [1]
Not Completed 18 21
Reason Not Completed
Adverse Event             1             4
Lost to Follow-up             1             4
Withdrawal by Subject             7             1
Protocol Violation             2             3
Study specific discontinuation criteria             4             8
Multiple reasons             3             1
[1]
Randomized patients
Arm/Group Title Symbicort Budesonide Total
Hide Arm/Group Description SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily Total of all reporting groups
Overall Number of Baseline Participants 127 123 250
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 123 participants 250 participants
16.6  (39.8) 14.9  (37.0) 15.6  (38.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 123 participants 250 participants
Female
84
  66.1%
80
  65.0%
164
  65.6%
Male
43
  33.9%
43
  35.0%
86
  34.4%
1.Primary Outcome
Title Morning Peak Expiratory Flow (AM PEF)
Hide Description Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 124 119
Least Squares Mean (Standard Error)
Unit of Measure: Liters/minutes
25.40  (6.0) 19.90  (6.5)
2.Secondary Outcome
Title Percentage of Participants With Pre-defined Asthma Events
Hide Description Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 127 123
Measure Type: Number
Unit of Measure: Percentage of Participants
25.20 31.70
3.Secondary Outcome
Title Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events"
Hide Description Percentage of participants with "Withdrawals Due to Pre-defined Asthma Events" as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 96 92
Measure Type: Number
Unit of Measure: Percentage of Participants
2.10 6.50
4.Secondary Outcome
Title Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Hide Description Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame Baseline, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 124 122
Least Squares Mean (Standard Error)
Unit of Measure: Liters
0.16  (0.03) 0.11  (0.03)
5.Secondary Outcome
Title Change From Baseline in a Evening Peak Expiratory Flow (PM PEF)
Hide Description Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 124 119
Least Squares Mean (Standard Error)
Unit of Measure: Liters/minutes
20.60  (6.2) 15.80  (6.7)
6.Secondary Outcome
Title Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks
Hide Description

Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate.

Daily scale:

  • 0 = No symptoms
  • 1 = Mild symptoms
  • 2 = Moderate symptoms
  • 3 = Severe symptoms
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.40  (0.01) -0.30  (0.01)
7.Secondary Outcome
Title Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks
Hide Description

Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate.

Daily scale:

  • 0 = No symptoms
  • 1 = Mild symptoms
  • 2 = Moderate symptoms
  • 3 = Severe symptoms
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.40  (0.01) -0.30  (0.01)
8.Secondary Outcome
Title Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks
Hide Description Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of nights
5.40  (1.7) 5.50  (1.9)
9.Secondary Outcome
Title Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment
Hide Description Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: puffs/day
-0.80  (0.20) -0.60  (0.20)
10.Secondary Outcome
Title Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment
Hide Description Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
19.70  (3.30) 17.70  (3.50)
11.Secondary Outcome
Title Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment
Hide Description Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Time Frame Baseline (run-in) and throughout 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Least Squares Mean (Standard Error)
Unit of Measure: Percentage of days
24.40  (3.30) 21.00  (3.50)
12.Secondary Outcome
Title Subject Global Assessment
Hide Description The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as “Yes” and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Measure Type: Number
Unit of Measure: Percent of Participants
88.70 86.30
13.Secondary Outcome
Title Physician Global Assessment
Hide Description The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as “Yes” and points 3, 4, 5 as "No". Percent of Participants that gave positive responses.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 125 119
Measure Type: Number
Unit of Measure: Perscentage of Participants
92.00 84.60
14.Secondary Outcome
Title Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index
Hide Description Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
87.20  (1.97) 82.50  (2.08)
15.Secondary Outcome
Title Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication
Hide Description Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
budesonide HFA pMDI 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
90.67  (1.79) 86.66  (1.89)
16.Secondary Outcome
Title Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications
Hide Description Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects 18 years and older, who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
budesonide HFA pMDI 160 μg x 2 actuations twice daily
Overall Number of Participants Analyzed 104 100
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
88.45  (2.34) 80.60  (2.47)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily budesonide HFA pMDI 160 μg x 2 actuations twice daily
All-Cause Mortality
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   4/127 (3.15%)   0/123 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Hemorrhage  1  1/127 (0.79%)  0/123 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  2  1/127 (0.79%)  0/123 (0.00%) 
Infections and infestations     
Cellulitis  2  1/127 (0.79%)  0/123 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Status Asthmaticus  2  1/127 (0.79%)  0/123 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   69/127 (54.33%)   48/123 (39.02%) 
Ear and labyrinth disorders     
Ear Pain  1  3/127 (2.36%)  0/123 (0.00%) 
Gastrointestinal disorders     
Toothache  1  0/127 (0.00%)  3/123 (2.44%) 
General disorders     
Pain  1  3/127 (2.36%)  0/123 (0.00%) 
Pyrexia  1  3/127 (2.36%)  0/123 (0.00%) 
Infections and infestations     
Bronchitis  1  3/127 (2.36%)  0/123 (0.00%) 
Influenza  1  3/127 (2.36%)  0/123 (0.00%) 
Nasopharyngitis  1  7/127 (5.51%)  0/123 (0.00%) 
Pharyngitis Streptococcal  1  3/127 (2.36%)  0/123 (0.00%) 
Sinusitis  1  0/127 (0.00%)  3/123 (2.44%) 
Upper Respiratory Tract Infection  1  0/127 (0.00%)  4/123 (3.25%) 
Viral Upper Respiratory Tract Infection  1  7/127 (5.51%)  6/123 (4.88%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/127 (2.36%)  5/123 (4.07%) 
Back Pain  1  5/127 (3.94%)  3/123 (2.44%) 
Nervous system disorders     
Headache  1  19/127 (14.96%)  14/123 (11.38%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  3/127 (2.36%)  0/123 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/127 (3.15%)  7/123 (5.69%) 
Nasal Congestion  1  8/127 (6.30%)  0/123 (0.00%) 
Pharyngolaryngeal Pain  1  0/127 (0.00%)  3/123 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00419757     History of Changes
Other Study ID Numbers: D5896C00021
First Submitted: January 5, 2007
First Posted: January 9, 2007
Results First Submitted: May 20, 2009
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012