Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans (Titan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00702325
First received: June 19, 2008
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.


Condition Intervention Phase
Asthma
Drug: Budesonide / formoterol fumarate (SYMBICORT)
Drug: Budesonide
Phase 4

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-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period


Secondary Outcome Measures:
  • Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated.

  • Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication)

  • Number of Withdrawals Due to a Predefined Asthma Event [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds)

  • Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period

  • Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)

  • Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS)

  • Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away

  • Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S]) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  • Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma.

  • Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS) [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period.

  • Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.

  • Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away

  • Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work.


Enrollment: 311
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Budesonide / formoterol fumarate (SYMBICORT)
160/4.5 μg x 2 actuations twice daily (bid)
Other Name: SYMBICORT
Active Comparator: 2 Drug: Budesonide
inhalation powder 180 μg x 2 inhalations bid (PULMICORT)
Other Name: PULMICORT

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American (self-reported)
  • Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
  • FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria:

  • Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
  • Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
  • Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
  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: NCT00702325

  Show 58 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Ubaldo Martin, MD AstraZeneca
Study Director: Tomas LG Andersson AstraZeneca
  More 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: NCT00702325     History of Changes
Other Study ID Numbers: D589BL00003
Study First Received: June 19, 2008
Results First Received: September 20, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Asthma

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

ClinicalTrials.gov processed this record on October 23, 2014