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Completed

NCT Number: NCT01704495

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

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

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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

18 year–150 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Gotse Delchev, Bulgaria

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

AZD5069

Drug

AZD5069 oral capsules self-administered twice daily.

Placebo

Drug

Placebo oral capsules self-administered twice daily.

Primary outcomes

  1. Rate of Severe Asthma Exacerbations During 6 Months

    Time frame: From start of treatment up to 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: NIMBUS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2012
Registry last updated
Mar 1, 2016

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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