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A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

Primary Purpose

Persistent Asthma

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Beclomethasone dipropionate breath-actuated inhaler

Placebo breath-actuated inhaler

albuterol/salbutamol

About this trial

This is an interventional treatment trial for Persistent Asthma focused on measuring asthma, breath-actuated inhaler, beclomethasone

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
Current asthma therapy: The patient is currently being treated with 1 of the following:
1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
The patient is a pregnant or lactating female or plans to become pregnant.
The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
Other criteria apply, please contact the investigator for more information

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

BDP 80 mcg BAI

BDP 160 mcg BAI

Placebo BAI

Arm Description

40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

Placebo breath-actuated inhaler (BAI) twice daily.

Outcomes

Primary Outcome Measures

Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received

The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.

Secondary Outcome Measures

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period

Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.

Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12

Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit.

Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,

Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of alert criteria is: FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1). Other criteria as defined in the protocol.

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of alert criteria is: FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1). Other criteria as defined in the protocol.

Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.

Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period

Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are: Sitting systolic BP (low); <=90 mm Hg and decrease of >=20 mm Hg from baseline Sitting diastolic BP (high): >=105 mm Hg and increase of >=15 mm Hg from baseline Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose).

Participants With Findings During Oropharyngeal Examination During Treatment

Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.

Full Information

NCT ID

NCT02040779

First Posted

January 16, 2014

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02040779

Brief Title

A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 26, 2013 (undefined)

Primary Completion Date

December 24, 2014 (Actual)

Study Completion Date

December 24, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistent Asthma

Keywords

asthma, breath-actuated inhaler, beclomethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BDP 80 mcg BAI

Arm Type

Experimental

Arm Description

40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

Arm Title

BDP 160 mcg BAI

Arm Type

Experimental

Arm Description

80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

Arm Title

Placebo BAI

Arm Type

Placebo Comparator

Arm Description

Placebo breath-actuated inhaler (BAI) twice daily.

Intervention Type

Drug

Intervention Name(s)

Beclomethasone dipropionate breath-actuated inhaler

Other Intervention Name(s)

BDP

Intervention Description

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Intervention Type

Drug

Intervention Name(s)

Placebo breath-actuated inhaler

Intervention Description

Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Intervention Type

Drug

Intervention Name(s)

albuterol/salbutamol

Other Intervention Name(s)

bronchodilators

Intervention Description

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Primary Outcome Measure Information:

Title

Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received

Description

Time Frame

Baseline (Day 1 predose), weeks 2, 4, 8 and 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period

Description

Time Frame

Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Title

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

Description

Time Frame

Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Title

Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12

Description

Time Frame

Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Title

Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

Description

Time Frame

Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Title

Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

Description

Time Frame

Treatment period: daily from Day 1 up to Week 12

Title

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

Description

Time Frame

Treatment period: Day 1 up to Week 12

Title

Participants With Treatment-Emergent Adverse Events (TEAEs)

Description

Time Frame

Day 1 up to Week 12

Title

Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period

Description

Time Frame

Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12

Title

Participants With Findings During Oropharyngeal Examination During Treatment

Description

Time Frame

Visits at weeks 2, 4, 8, 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999). Current asthma therapy: The patient is currently being treated with 1 of the following: 1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV). Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information Exclusion Criteria: The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures. The patient is a pregnant or lactating female or plans to become pregnant. The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation. The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year. The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV. The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. Other criteria apply, please contact the investigator for more information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 12813

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10944

City

Mission Viejo

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10946

City

Orange

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10963

City

Rolling Hills Estates

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10960

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10973

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10975

City

San Jose

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10948

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10958

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10957

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 12814

City

Sarasota

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10962

City

Tallahassee

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12809

City

Savannah

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10947

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10943

City

Iowa City

State/Province

Iowa

Country

United States

Facility Name

Teva Investigational Site 10954

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 12940

City

Bethesda

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10955

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 10941

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Teva Investigational Site 10970

City

Columbia

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10968

City

Rolla

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10972

City

Bozeman

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 12941

City

Missoula

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 10942

City

Bellevue

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 10959

City

Skillman

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10945

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12810

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10974

City

Sylvania

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 12805

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 12942

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10951

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10940

City

Lake Oswego

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10952

City

Medford

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10956

City

Portland

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 12939

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 12806

City

Orangeburg

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 12811

City

Knoxville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 10969

City

Austin

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12812

City

Boerne

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10949

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10953

City

El Paso

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12807

City

Houston

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10950

City

New Braunfels

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10961

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12808

City

Waco

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10967

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 10964

City

Greenfield

State/Province

Wisconsin

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28886758

Citation

Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.

Results Reference

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Learn more about this trial

A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

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A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

Persistent Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial