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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

Brief Summary:
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Budesonide HFA pMDI Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma
Study Start Date : January 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Symbicort
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Drug: Budesonide/formoterol (SYMBICORT) pMDI
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Active Comparator: Budesonide
budesonide HFA pMDI 160 μg x 2 actuations twice daily
Drug: Budesonide HFA pMDI
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily



Primary Outcome Measures :
  1. Morning Peak Expiratory Flow (AM PEF) [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Pre-defined Asthma Events [ Time Frame: 12 weeks ]
    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

  2. Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events" [ Time Frame: 12 weeks ]
    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.

  3. Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, 2, 6 and 12 weeks ]
    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.

  4. Change From Baseline in a Evening Peak Expiratory Flow (PM PEF) [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    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.

  5. Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ]

    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

  6. Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ]

    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

  7. Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.

  8. Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    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.

  9. Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    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.

  10. Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ]
    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.

  11. Subject Global Assessment [ Time Frame: Baseline and week 12 ]
    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.

  12. Physician Global Assessment [ Time Frame: Baseline and week 12 ]
    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.

  13. Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index [ Time Frame: Week 12 ]
    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.

  14. Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication [ Time Frame: Week 12 ]
    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.

  15. Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications [ Time Frame: Week 12 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female, Hispanic (self-reported), > 12 years of age
  • Moderate to severe asthma requiring treatment with an inhaled corticosteroid
  • Diagnosis of asthma for at least 6 months

Exclusion Criteria:

  • Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
  • Any significant disease or disorder that may jeopardize a subject's safety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419757


  Show 39 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultquist, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00419757     History of Changes
Other Study ID Numbers: D5896C00021
First Posted: January 9, 2007    Key Record Dates
Results First Posted: August 27, 2012
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by AstraZeneca:
Moderate asthma
Severe asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists