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Trial record 3 of 16 for:    AZD 5069

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NIMBUS)

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ClinicalTrials.gov Identifier: NCT01704495
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Condition or disease Intervention/treatment Phase
Asthma Drug: AZD5069 Drug: Placebo Phase 2

Detailed Description:
A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study With an Optional Safety Extension Treatment Period up to 6 Months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients With Uncontrolled Persistent Asthma
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: AZD5069 5 mg
AZD5069 oral capsules self-administered twice daily
Drug: AZD5069
AZD5069 oral capsules self-administered twice daily.

Experimental: AZD5069 15 mg
AZD5069 oral capsules self-administered twice daily
Drug: AZD5069
AZD5069 oral capsules self-administered twice daily.

Experimental: AZD5069 45 mg
AZD5069 oral capsules self-administered twice daily
Drug: AZD5069
AZD5069 oral capsules self-administered twice daily.

Placebo Comparator: Placebo
Placebo oral capsules self-administered twice daily
Drug: Placebo
Placebo oral capsules self-administered twice daily.




Primary Outcome Measures :
  1. Rate of Severe Asthma Exacerbations During 6 Months [ Time Frame: From start of treatment up to 6 months ]

Secondary Outcome Measures :
  1. Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months [ Time Frame: From start of treatment up to 6 months ]
  2. Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions [ Time Frame: From start of treatment up to 6 months ]
  3. Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms [ Time Frame: From start of treatment up to 6 months ]
  4. Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 2 weeks after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

  5. Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 1 month after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

  6. Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 2 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

  7. Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 3 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

  8. Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 4 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

  9. Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 6 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

  10. Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 2 weeks after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis

  11. Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 1 month after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at one month are included in the analysis

  12. Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 2 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at two months are included in the analysis

  13. Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 3 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at three months are included in the analysis

  14. Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 4 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at four months are included in the analysis

  15. Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1 [ Time Frame: Baseline (Day 0) and 6 months after Day 0 ]
    Only patients with both a non-missing value at baseline and visit at six months are included in the analysis

  16. Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score [ Time Frame: Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months) ]
    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

  17. Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) [ Time Frame: Baseline (Day 0) and 6 months after Day 0 ]
    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

  18. Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score [ Time Frame: Baseline (Day 0), Treatment Period (1,3, and 6 months) ]
    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

  19. Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score [ Time Frame: Baseline (Day 0) and 6 months after Day 0 ]
    The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.

  20. Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28) ]
  21. Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56) ]
  22. Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84) ]
  23. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months) ]
  24. Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28) ]
  25. Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56) ]
  26. Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84) ]
  27. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months ]
  28. Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28) ]
  29. Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56) ]
  30. Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84) ]
  31. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months) ]
  32. Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28) ]
  33. Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56) ]
  34. Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84) ]
  35. Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms [ Time Frame: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months) ]
  36. Number of Participants With Well Controlled Asthma Weeks at Baseline [ Time Frame: Last 2 weeks before randomization ]
  37. Number of Well Controlled Asthma Weeks During Treatment [ Time Frame: Day 1to end of the 6 months treatment period ]
  38. Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline [ Time Frame: Last 2 weeks before randomization ]
  39. Number of Uncontrolled Persistent Asthma Weeks During Treatment [ Time Frame: Day 1 to end of the 6 months treatment period ]
  40. Mean Plasma Concentration of AZD5069 at Day 7 [ Time Frame: Day 7 ]
  41. Mean Plasma Concentration of AZD5069 at 1 Month [ Time Frame: at 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 150 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
  • Diagnosis of asthma for at least 12 months (GINA 2011)
  • Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
  • Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
  • Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

Exclusion Criteria:

  • Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
  • Patients with recurrent, latent, or chronic infections
  • Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
  • Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
  • Current smoker or smoking history of more than 20 pack years

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): NCT01704495


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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Bengt Larsson, MEDICAL SCIENCE DIRECTOR AZ Mondal R&D, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01704495     History of Changes
Other Study ID Numbers: D3551C00001
2012-001869-33
First Posted: October 11, 2012    Key Record Dates
Results First Posted: March 1, 2016
Last Update Posted: March 1, 2016
Last Verified: February 2016

Keywords provided by AstraZeneca:
Uncontrolled Asthma,
Exacerbation,
Safety

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases