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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419757
First received: January 5, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Budesonide/formoterol (SYMBICORT) pMDI
Drug: Budesonide HFA pMDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning Peak Expiratory Flow (AM PEF) [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants With Pre-defined Asthma Events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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

  • Percentage of Participants With "Withdrawals Due to Pre-defined Asthma Events" [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, 2, 6 and 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in a Evening Peak Expiratory Flow (PM PEF) [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]

    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

  • Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]

    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

  • Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate.

  • Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment [ Time Frame: Baseline (run-in) and throughout 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Subject Global Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.

  • Physician Global Assessment [ Time Frame: Baseline and week 12 ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 558
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419757

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

Additional Information:
No publications provided by AstraZeneca

Additional 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
Study First Received: January 5, 2007
Results First Received: May 20, 2009
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration

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
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014