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Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199598
Recruitment Status : Terminated (The decision to terminate has been taken by the Sponsor. The decision is not due to safety concerns but reflects business prioritizations of the company.)
First Posted : December 16, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The study is intended to assess the relative bioavailability of 2 different abediterol nebulised formulations (test) and the dry powder formulation (reference). The study results will provide information on the pharmacokinetic (PK) profile following use of the 3 devices to be used in further clinical development.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Abediterol (2.4 μg) Drug: Abediterol (4.8 μg) Drug: Abediterol (2.5 μg) Phase 1

Detailed Description:

This study will be an open-label, randomized, 4-period, single-dose, single-center, crossover study with a William's design in healthy subjects (males).

The study will comprise:

  1. A screening period of maximum 28 days;
  2. Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with abediterol (Day -1) until at least 48 hours following dosing for collection of PK samples; discharged on the morning of Day 3; and
  3. A final safety post-treatment visit within 14 days after the last administration of abediterol.

There will be a minimum washout period of 14 days between each treatment period.

Each subject will be involved in the study for approximately 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Single-center, Randomized, 4-period, Single Dose, Crossover Study to Assess the Relative Bioavailability of Abediterol Inhaled Via Two Different Nebulizers and Via Dry Powder Inhaler in Healthy Subjects.
Actual Study Start Date : January 28, 2020
Actual Primary Completion Date : April 3, 2020
Actual Study Completion Date : April 3, 2020

Arm Intervention/treatment
Experimental: Treatment A (test product): Abediterol (2.4 μg)
Randomized subjects will receive single dose treatment of Abediterol nebuliser solution for inhalation via PARI LC SPRINT nebulizer following an overnight fast of at least 8 hours
Drug: Abediterol (2.4 μg)
2.4 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser

Experimental: Treatment B (Test Product): Abediterol (4.8 μg)
Randomized subjects will receive single dose treatment of Abediterol nebuliser solution for inhalation via PARI LC SPRINT nebulizer following an overnight fast of at least 8 hours
Drug: Abediterol (4.8 μg)
4.8 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser

Experimental: Treatment C(Test Product):Abediterol(2.4 μg)
Randomized subjects will receive single dose treatment of Abediterol nebuliser solution for inhalation via OMRON NE-C900-E nebulizer following an overnight fast of at least 8 hours
Drug: Abediterol (2.4 μg)
2.4 μg (delivered dose) abediterol via OMRON NE-C900-E nebuliser

Experimental: Treatment D (Reference Product): Abediterol (2.5 μg)
Randomized subjects will receive single dose treatment of Abediterol (as napadisylate) inhalation powder via dry powder inhaler (DPI) following an overnight fast of at least 8 hours
Drug: Abediterol (2.5 μg)
2.5 μg (nominal dose) abediterol via DPI, reference




Primary Outcome Measures :
  1. Geometric mean ratios and 90% confidence intervals for area under plasma (AUC) for test versus abediterol reference treatments [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To estimate the relative bioavailability of abediterol following inhalation via PARI LC SPRINT nebulizer (2 dose levels) or via OMRON NE-C900-E nebulizer (1 dose level) compared to inhalation via DPI SD2FL (1 dose level)

  2. Geometric mean ratios and 90% confidence intervals for area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC[0-t]) for test versus reference abediterol treatments [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To estimate the relative bioavailability of abediterol following inhalation via PARI LC SPRINT nebulizer (2 dose levels) or via OMRON NE-C900-E nebulizer (1 dose level) compared to inhalation via DPI SD2FL (1 dose level)

  3. Geometric mean ratios and 90% confidence intervals for maximum observed plasma concentration (Cmax) the for test versus reference abediterol treatments [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To estimate the relative bioavailability of abediterol following inhalation via PARI LC SPRINT nebulizer (2 dose levels) or via OMRON NE-C900-E nebulizer (1 dose level) compared to inhalation via DPI SD2FL (1 dose level)


Secondary Outcome Measures :
  1. AUC for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  2. AUC (0-t) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  3. Cmax for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  4. Area under the plasma concentration-time curve from time zero to 24 hours [AUC (0-24)] for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  5. Maximum concentration (tmax) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  6. Terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  7. Terminal elimination rate constant (λz) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  8. Time of last quantifiable plasma concentration (tlast) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  9. Apparent total body clearance of drug from plasma after extravascular administration (CL/F) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  10. Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  11. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) for each abediterol treatment [ Time Frame: On Day 1: pre-dose, 5 min [only for DPI], 12, 30, and 45 min, and 1, 2, 4, 6, 8, 12 hours post-dose, on Day 2: 24 and 36 hours post-dose, on Day 3: 48 hours post-dose, on Day 4-7: 72, 96, 120 and 144 hours post-dose. ]
    To evaluate the PK profile of abediterol when administered via the 3 devices (DPI and 2 nebulisers)

  12. Number of subjects with adverse events [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  13. Number of subjects with abnormal electrocardiogram (ECG) [ Time Frame: From Screening (Day -28), Day -1 until Day 3 ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  14. Number of subjects with abnormal telemetry [ Time Frame: Day -1, 1 (pre-dose to 12 hours from the start of study drug administration) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  15. Number of subjects with abnormal vital signs [ Time Frame: From Screening (Day -28) until Day 3 ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  16. Number of subjects with abnormal physical examination [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  17. Number of subjects with abnormal spirometry [ Time Frame: At Screening (Day -28) and Day 1 ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  18. Number of subjects with abnormal taste questionnaire [ Time Frame: Day 1 ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  19. Number of subjects with abnormal White blood cell (WBC) count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  20. Number of subjects with abnormal Red blood cell (RBC) count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  21. Number of subjects with abnormal Hemoglobin (Hb) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  22. Number of subjects with abnormal Hematocrit (HCT) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  23. Number of subjects with abnormal Mean corpuscular volume (MCV) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  24. Number of subjects with abnormal Mean corpuscular hemoglobin (MCH) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  25. Number of subjects with abnormal Mean corpuscular hemoglobin concentration (MCHC) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  26. Number of subjects with abnormal Neutrophils absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  27. Number of subjects with abnormal Lymphocytes absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  28. Number of subjects with abnormal Monocytes absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  29. Number of subjects with abnormal Eosinophils absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  30. Number of subjects with abnormal Basophils absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  31. Number of subjects with abnormal Reticulocytes absolute count [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  32. Number of subjects with abnormal sodium [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  33. Number of subjects with abnormal pottasium [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  34. Number of subjects with abnormal urea [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  35. Number of subjects with abnormal creatinine [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  36. Number of subjects with abnormal albumin [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  37. Number of subjects with abnormal calcium [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  38. Number of subjects with abnormal phosphate [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  39. Number of subjects with abnormal glucose (fasting) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  40. Number of subjects with abnormal C-reactive protein (CRP) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  41. Number of subjects with abnormal Alkaline phosphatase (ALP) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  42. Number of subjects with abnormal Alanine aminotransferase (ALT) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  43. Number of subjects with abnormal Aspartate aminotransferase (AST) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  44. Number of subjects with abnormal Total Bilirubin [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  45. Number of subjects with abnormal Unconjugated bilirubin [ Time Frame: Screening (Day -28), Day -1, 1 and 14 days after last dose ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  46. Number of subjects with abnormal Thyroid-stimulating hormone (TSH) [ Time Frame: Screening (Day -28) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  47. Number of subjects with abnormal urinalysis (glucose, blood and protein) [ Time Frame: Screening (Day -28) and Day -1 ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  48. Number of subjects with abnormal Gamma glutamyl transpeptidase (GGT) [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects

  49. Number of subjects with abnormal platelet [ Time Frame: From Screening (Day -28) until follow-up (14 days after last dose) ]
    To further assess the safety of single doses administration of abediterol in healthy subjects



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent prior to any study-specific procedures.
  2. Healthy male subjects aged 18 - 45 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
  3. Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
  4. Subject is able to understand and communicate in German.
  5. Willing and able to comply with all required study procedures.

Exclusion Criteria:

  1. History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
  2. History or presence of gastrointestinal (GI), hepatic or renal disease, or any other conditions (e.g., including Gilbert's syndrome, gallstone and cholecystectomy) known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  3. History of tuberculosis, any other significant lung diseases like surgeries, asthma, COPD.
  4. Upper respiratory tract infections within 14 days of the first study day, or lower respiratory tract infection within 3 months prior to screening.
  5. Any clinically significant illness, medical/surgical procedure, or trauma within

4 weeks of the first administration of IMP. 6 Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and first admission to the study unit (first treatment period) as judged by the PI. 7 Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit (first treatment period), as judged by the PI, and defined as:

  1. Systolic BP <90 mmHg or ≥140 mmHg and diastolic BP <50 mmHg or

    ≥90 mmHg

  2. Heart rate <50 beats per minute [bpm] or >90 bpm Note: Assessments may be repeated once to confirm values. 8 Any clinically significant abnormalities on 12-lead ECG at screening and first admission to the study unit (first treatment period), as judged by the PI, and defined as:

(1) Sick sinus syndrome (2) Arrhythmia (3) Prolonged QT interval corrected using Fridericia's formula (QTcF) > 450 ms (4) Family history of long QT syndrome, persistent or intermittent bundle branch block (BBB), AV block grade II or III 9 Any positive result on screening for serum hepatitis B surface antigen (HBsAg) OR anti-hepatitis B core antigen (HBc) antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody. 10 Has received another new chemical and biologic entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded. 11 Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening. 12 History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to abediterol. 13 Current smokers or those who have smoked or used nicotine products (including e- cigarettes; > 10 pack-year) within the 3 months prior to screening. 14 Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP. 15 Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.

16 Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI or positive screen for drugs of abuse, cotinine, and/or alcohol at screening or on each admission to the Clinical Unit. 17 Subjects with a pregnant partner. 18 Involvement of any AstraZeneca, Parexel or study site employee or their close relatives. 19 Subjects who have previously received abediterol. 20 Judgement by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements. 21 Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.


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): NCT04199598


Locations
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Germany
Research Site
Berlin, Germany, 14050
Sponsors and Collaborators
AstraZeneca
Parexel
Investigators
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Principal Investigator: Dr. med. Rainard Fuhr Parexel
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04199598    
Other Study ID Numbers: D6541C00001
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AstraZeneca:
Open-label
Long-acting beta-2 agonist
COPD
Bioavailability
Phase 1
Abediterol
Healthy subjects
Crossover
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases