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Completed

NCT Number: NCT00702325

Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Pell City, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide / formoterol fumarate (SYMBICORT)

Drug

160/4.5 μg x 2 actuations twice daily (bid)

Other names: SYMBICORT

Budesonide

Drug

inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Other names: PULMICORT

Primary outcomes

  1. Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period

    Time frame: Baseline to 12 weeks

    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

Secondary outcomes

  1. Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  2. Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  3. Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period

  4. Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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.

  5. Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry

    Time frame: 12 weeks

    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)

  6. Number of Withdrawals Due to a Predefined Asthma Event

    Time frame: 12 weeks

    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)

  7. Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  8. Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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)

  9. Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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)

  10. Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  11. Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  12. Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  13. Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  14. Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  15. Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  16. Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period

    Time frame: Baseline to 12 weeks

    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

  17. 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

    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

  18. 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

    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

  19. 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

    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.

  20. Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS)

    Time frame: Baseline to 12 weeks

    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.

  21. 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

    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.

  22. 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

    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

  23. 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

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Titan

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2008
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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