Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION)

May 9, 2023 updated by: AstraZeneca

A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (DESTINATION)

Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab versus placebo in Adults and Adolescents (12 years of age and older) with a history of asthma exacerbations and inadequately controlled severe asthma receiving medium or high dose inhaled corticosteroid (ICS) plus at least one additional asthma controller medication with or without oral corticosteroids

Following treatment, subjects will enter a follow-up phase, determined by the predecessor study they had previously completed. Subjects will not receive IP during the follow-up phase. For subjects who entered the study from study D5180C00007 and did not meet IP Discontinuation criteria, the follow-up phase will extend from week 104 to Week 140. Subjects who entered the study from study D5180C00009 will have their follow-up phase extend to week 116.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
951

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1027
        • Research Site
      • Buenos Aires, Argentina, C1414AIF
        • Research Site
      • Caba, Argentina, C1425BEN
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1425
        • Research Site
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Mendoza, Argentina, 5500
        • Research Site
      • Nueve de julio, Argentina, B6500EZL
        • Research Site
      • Quilmes, Argentina, B1878FNR
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Research Site
      • San Miguel de Tucuman, Argentina, T4000IAQ
        • Research Site
  • Australia
      • Kent Town, Australia, 5067
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • New Lambton, Australia, 2310
        • Research Site
      • Spearwood, Australia, 6163
        • Research Site
      • Westmead, Australia, 2145
        • Research Site
      • Woolloongabba, Australia, 4102
        • Research Site
  • Austria
      • Wien, Austria, 1130
        • Research Site
      • Wien, Austria, 1090
        • Research Site
  • Brazil
      • Blumenau, Brazil, 89030-101
        • Research Site
      • Botucatu, Brazil, 18618-970
        • Research Site
      • Curitiba, Brazil, 80060-900
        • Research Site
      • Porto Alegre, Brazil, 90610-000
        • Research Site
      • Porto Alegre, Brazil, 91350-200
        • Research Site
      • Porto Alegre, Brazil, 9002-060
        • Research Site
      • Porto Alegre, Brazil, 90020-090
        • Research Site
      • Recife, Brazil, 50070-550
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      • Salvador, Brazil, 40060-330
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      • Santo Andre, Brazil, 09080-110
        • Research Site
      • Sao Bernardo do Campo, Brazil, 09750-420
        • Research Site
      • Sorocaba, Brazil, 18040-425
        • Research Site
  • Canada
      • Quebec, Canada, G1G 3Y8
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
      • Sherwood Park, Alberta, Canada, T8L 0N2
        • Research Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Research Site
      • Mississauga, Ontario, Canada, L5A 3V4
        • Research Site
      • Ottawa, Ontario, Canada, K1H 1E4
        • Research Site
      • Windsor, Ontario, Canada, N8X 1T3
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Research Site
      • St Charles Borromee, Quebec, Canada, J6E 2B4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G8T 7A1
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  • France
      • Brest Cedex 2, France, 29609
        • Research Site
      • Le Kremlin-Bicêtre, France, 94270
        • Research Site
      • Lyon Cedex 04, France, 69317
        • Research Site
      • Marseille Cedex 20, France, 13915
        • Research Site
      • Montpellier, France, 34090
        • Research Site
      • Nantes, France, 44093
        • Research Site
      • Paris, France, 75012
        • Research Site
      • Paris, France, 75018
        • Research Site
      • Pessac, France, 33604
        • Research Site
      • Strasbourg Cedex, France, 67091
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  • Germany
      • Bamberg, Germany, 96049
        • Research Site
      • Berlin, Germany, 10367
        • Research Site
      • Berlin, Germany, 10717
        • Research Site
      • Berlin, Germany, 10969
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Frankfurt am Main, Germany, 60596
        • Research Site
      • Hamburg, Germany, 20354
        • Research Site
      • Hamburg, Germany, 22299
        • Research Site
      • Hannover, Germany, 30625
        • Research Site
      • Hannover, Germany, D-30173
        • Research Site
      • Koblenz, Germany, 56068
        • Research Site
      • Landsberg, Germany, 86899
        • Research Site
      • Leipzig, Germany, 04357
        • Research Site
      • Lübeck, Germany, 23552
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar Saba, Israel, 49281
        • Research Site
      • Rehovot, Israel, 7661041
        • Research Site
  • Korea, Republic of
      • Bucheon-si, Korea, Republic of, 420-767
        • Research Site
      • Cheongju-si, Korea, Republic of, 28644
        • Research Site
      • Daegu, Korea, Republic of, 41404
        • Research Site
      • Daegu, Korea, Republic of, 42415
        • Research Site
      • Jeju-do, Korea, Republic of, 63241
        • Research Site
      • Jeonju-si, Korea, Republic of, 54907
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Seoul, Korea, Republic of, 02447
        • Research Site
      • Seoul, Korea, Republic of, 03312
        • Research Site
      • Seoul, Korea, Republic of, 08308
        • Research Site
      • Seoul, Korea, Republic of, 150-713
        • Research Site
      • Seoul, Korea, Republic of, 158-710
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
  • Poland
      • Kraków, Poland, 31-559
        • Research Site
      • Wrocław, Poland, 53-301
        • Research Site
      • Łódź, Poland, 90-153
        • Research Site
  • Russian Federation
      • Izhevsk, Russian Federation, 426035
        • Research Site
      • Moscow, Russian Federation, 115093
        • Research Site
      • Moscow, Russian Federation, 115522
        • Research Site
      • St-Petersburg, Russian Federation, 193231
        • Research Site
  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21423
        • Research Site
      • Jeddah, Saudi Arabia, 22252
        • Research Site
  • South Africa
      • Bellville, South Africa, 7530
        • Research Site
      • Cape Town, South Africa, 7700
        • Research Site
      • Cape Town, South Africa, 7764
        • Research Site
      • Durban, South Africa, 4001
        • Research Site
      • Durban, South Africa, 4091
        • Research Site
      • Durban, South Africa, 4092
        • Research Site
      • Durban, South Africa, 4450
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      • Johannesburg, South Africa, 1724
        • Research Site
      • Johannesburg, South Africa, 2113
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      • Johannesburg, South Africa, 1829
        • Research Site
      • Lenasia Ext8, South Africa, 1820
        • Research Site
      • Meadowdale, Germiston, South Africa, 1614
        • Research Site
      • Middelburg, South Africa, 1055
        • Research Site
      • Parow, South Africa, 7505
        • Research Site
      • Umkomaas, South Africa, 4170
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 235
        • Research Site
  • Turkey
      • Ankara, Turkey, 06230
        • Research Site
      • Ankara, Turkey, 06280
        • Research Site
      • Bursa, Turkey, 16059
        • Research Site
      • Istanbul, Turkey, 34098
        • Research Site
  • Ukraine
      • Dnipro, Ukraine, 49007
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Research Site
      • Kharkiv Region, Ukraine, 61075
        • Research Site
      • Kherson, Ukraine, 73000
        • Research Site
      • Lutsk, Ukraine, 43000
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Research Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Research Site
    • California
      • Bakersfield, California, United States, 93301
        • Research Site
      • Huntington Beach, California, United States, 92647
        • Research Site
      • Long Beach, California, United States, 90808
        • Research Site
      • Los Angeles, California, United States, 90025
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Northridge, California, United States, 91324
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Rolling Hills Estates, California, United States, 90274
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
      • Westminster, California, United States, 92683
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Research Site
    • Florida
      • Kissimmee, Florida, United States, 34744
        • Research Site
      • Kissimmee, Florida, United States, 34746
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
      • Sarasota, Florida, United States, 34239
        • Research Site
      • Tampa, Florida, United States, 33607
        • Research Site
      • Winter Park, Florida, United States, 32789-4681
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Research Site
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Research Site
    • Maryland
      • White Marsh, Maryland, United States, 21162
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
    • New Jersey
      • Northfield, New Jersey, United States, 08225
        • Research Site
    • New York
      • Bronx, New York, United States, 10459
        • Research Site
      • Bronx, New York, United States, 10461
        • Research Site
      • Brooklyn, New York, United States, 11235
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Research Site
      • Durham, North Carolina, United States, 27705
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Cincinnati, Ohio, United States, 45236
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
      • Columbia, South Carolina, United States, 29204
        • Research Site
      • Greenville, South Carolina, United States, 29607
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79109
        • Research Site
      • Boerne, Texas, United States, 78006
        • Research Site
      • McKinney, Texas, United States, 75069
        • Research Site
      • McKinney, Texas, United States, 75071
        • Research Site
      • Plano, Texas, United States, 75093
        • Research Site
      • San Antonio, Texas, United States, 78251
        • Research Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Research Site
    • Wisconsin
      • Cudahy, Wisconsin, United States, 53110
        • Research Site
      • Madison, Wisconsin, United States, 53792
        • Research Site
  • Vietnam
      • Ha Noi, Vietnam, 100000
        • Research Site
      • Hanoi, Vietnam, 10000
        • Research Site
      • Ho Chi Minh, Vietnam, 700000
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 81 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provision of signed and dated written informed consent
  • Negative urine test for female subjects of childbearing potential prior to administration of IP at visit 1
  • Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of IP.
  • Female or male subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either study D5180C00007 (NAVIGATOR) or D5180C00009 (SOURCE)

To enter the extended follow-up phase of the study, the following inclusion criteria also apply:

  • Provision of signed and dated Addendum for Extended Follow-up to informed consent, as well as assent by adolescent subjects where applicable, prior to any mandatory study specific procedures, sampling and analyses before Extended Follow Up.
  • Must have entered DESTINATION from D5180C00007 study and have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the EOT Visit.

Exclusion Criteria:

  • Any clinically important pulmonary disease other than asthma
  • Any disorder, including, but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable
  • History of chronic alcohol or drug abuse within 12 months prior to visit 1
  • Current malignancy or malignancy that developed during a predecessor study
  • Major surgery or planned surgical procedures requiring general anesthesia or inpatient status for > 1 day during the conduct of the study
  • Treatment with systemic immunosuppressive/immunomodulating drugs except for OCS used in the treatment of asthma/asthma exacerbations within the last 12 weeks prior to randomization
  • Concurrent enrolment in another clinical study involving an IP
  • Any clinically meaningful abnormal finding in physical examination, vital signs, ECG,haematology, clinical chemistry, or urinalysis during the predecessor study
  • Pregnant, breastfeeding, or lactating

To enter the extended follow-up phase of the study (which extends from week 104 to week 140), the following exclusion criteria also apply:

  • Discontinuation of IP during the treatment period of DESTINATION.
  • Entered DESTINATION from D5180C00009 (SOURCE) study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo: Placebo subcutaneous injection
Other: Placebo
Placebo subcutaneous injection
Experimental: Tezepelumab
Tezepelumab subcutaneous injection
Biological: Tezepelumab
Tezepelumab subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exposure Adjusted Incidence Rates of AEs/SAEs
Time Frame: Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Includes adverse events with an onset date between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set. Exposure adjusted rates are defined as number of subjects with AEs divided by total time at risk across all subjects, multiplied by 100
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Total Time at Risk
Time Frame: Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
Includes time between the date of first dose of IP in the predecessor and minimum (date of last dose of IP + 33 days, date of death, date of study withdrawal, day prior to start of another biologic). The analysis is based on the Safety Analysis Set.
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Annualized Asthma Exacerbation Rate (AAER)
Time Frame: Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.
The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
Baseline (Week 0 in predecessor study) to Week 104. For subjects switching treatments from placebo in the predecessor to tezepelumab in DESTINATION, all data collected after first dose of tezepelumab are excluded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Menzies-Gow, MD, Royal Brompton Hospital, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5180C00018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Dietary Supplements

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