Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

November 30, 2016 updated by: AstraZeneca

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

2508

Phase

  • 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

      • Buenos Aires, Argentina
        • Research Site
      • Caba, Argentina
        • Research Site
      • Ciudad Autónoma de Bs. As., Argentina
        • Research Site
      • Ciudad de Buenos Aires, Argentina
        • Research Site
      • Concepción del Uruguay, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
      • Córdoba, Argentina
        • Research Site
      • Florida, Argentina
        • Research Site
      • Godoy Cruz, Argentina
        • Research Site
      • La Plata, Argentina
        • Research Site
      • Mar del Plata, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
      • Ranelagh, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
      • San Miguel de Tucuman, Argentina
        • Research Site
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Sherwood Park, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada
        • Research Site
      • Hamilton, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • St Charles Borromee, Quebec, Canada
        • Research Site
      • Concepcion, Chile
        • Research Site
      • Quillota, Chile
        • Research Site
      • Santiago, Chile
        • Research Site
      • Talcahuano, Chile
        • Research Site
      • Valparaiso, Chile
        • Research Site
      • Viña del Mar, Chile
        • Research Site
      • Aschaffenburg, Germany
        • Research Site
      • Bamberg, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Frankfurt, Germany
        • Research Site
      • Frankfurt/Main, Germany
        • Research Site
      • Geesthacht, Germany
        • Research Site
      • Gelsenkirchen, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hannover, Germany
        • Research Site
      • Herford, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • München, Germany
        • Research Site
      • Neu-Isenburg, Germany
        • Research Site
      • Rostock, Germany
        • Research Site
      • Rüdersdorf, Germany
        • Research Site
      • Witten, Germany
        • Research Site
      • Asahi-shi, Japan
        • Research Site
      • Chiyoda-ku, Japan
        • Research Site
      • Chuo-ku, Japan
        • Research Site
      • Fukuoka-shi, Japan
        • Research Site
      • Himeji-shi, Japan
        • Research Site
      • Hiroshima-shi, Japan
        • Research Site
      • Itabashi-ku, Japan
        • Research Site
      • Kagoshima-shi, Japan
        • Research Site
      • Kishiwada-shi, Japan
        • Research Site
      • Kobe-shi, Japan
        • Research Site
      • Kokubunji-shi, Japan
        • Research Site
      • Matsue-shi, Japan
        • Research Site
      • Minato-ku, Japan
        • Research Site
      • Mizunami-shi, Japan
        • Research Site
      • Niigata-shi, Japan
        • Research Site
      • Obihiro-shi, Japan
        • Research Site
      • Oita-shi, Japan
        • Research Site
      • Ota-shi, Japan
        • Research Site
      • Sagamihara-shi, Japan
        • Research Site
      • Sakai-shi, Japan
        • Research Site
      • Sakaide-shi, Japan
        • Research Site
      • Sapporo-shi, Japan
        • Research Site
      • Sendai-shi, Japan
        • Research Site
      • Setagaya-ku, Japan
        • Research Site
      • Shibuya-ku, Japan
        • Research Site
      • Shinagawa-ku, Japan
        • Research Site
      • Sumida-ku, Japan
        • Research Site
      • Takamatsu-shi, Japan
        • Research Site
      • Toshima-ku, Japan
        • Research Site
      • Tsukubo-gun, Japan
        • Research Site
      • Yokohama-shi, Japan
        • Research Site
      • Iloilo City, Philippines
        • Research Site
      • Lipa City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
      • Aleksandrów Łódzki, Poland
        • Research Site
      • Białystok, Poland
        • Research Site
      • Bielsko Biala, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Bystra Śląska, Poland
        • Research Site
      • Gdańsk, Poland
        • Research Site
      • Gorzów Wlkp, Poland
        • Research Site
      • Karczew, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Koszalin, Poland
        • Research Site
      • Kraków, Poland
        • Research Site
      • Lubin, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Ostrów Wielkopolski, Poland
        • Research Site
      • Poznań, Poland
        • Research Site
      • Ruda Slaska, Poland
        • Research Site
      • Rzeszów, Poland
        • Research Site
      • Skierniewice, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Tarnów, Poland
        • Research Site
      • Toruń, Poland
        • Research Site
      • Trzebnica, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Wieluń, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site
      • Wrocław, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
      • Łódź, Poland
        • Research Site
      • Łęczna, Poland
        • Research Site
      • Żnin, Poland
        • Research Site
      • Bragadiru, Romania
        • Research Site
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Constanta, Romania
        • Research Site
      • Deva, Romania
        • Research Site
      • Iasi, Romania
        • Research Site
      • Timisoara, Romania
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Luleå, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Chernivtsi, Ukraine
        • Research Site
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Ivano-Frankivsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Lutsk, Ukraine
        • Research Site
      • Mykolayiv, Ukraine
        • Research Site
      • Uzhgorod, Ukraine
        • Research Site
      • Vinnytsia, Ukraine
        • Research Site
      • Vinnytsya, Ukraine
        • Research Site
      • Zaporizhzhia, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
    • Alabama
      • Andalusia, Alabama, United States
        • Research Site
      • Birmingham, Alabama, United States
        • Research Site
    • Arizona
      • Flagstaff, Arizona, United States
        • Research Site
      • Glendale, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Alhambra, California, United States
        • Research Site
      • Anaheim, California, United States
        • Research Site
      • Beverly Hills, California, United States
        • Research Site
      • Garden Grove, California, United States
        • Research Site
      • Lakewood, California, United States
        • Research Site
      • North Hollywood, California, United States
        • Research Site
      • Northridge, California, United States
        • Research Site
      • Palmdale, California, United States
        • Research Site
      • Rancho Mirage, California, United States
        • Research Site
      • Redondo Beach, California, United States
        • Research Site
      • Rolling Hills Estate, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • Stockton, California, United States
        • Research Site
      • Thousand Oaks, California, United States
        • Research Site
      • Upland, California, United States
        • Research Site
      • Ventura, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
      • Westminister, California, United States
        • Research Site
      • Woodland, California, United States
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    • Colorado
      • Centennial, Colorado, United States
        • Research Site
      • Colorado Springs, Colorado, United States
        • Research Site
      • Wheat Ridge, Colorado, United States
        • Research Site
    • Florida
      • Celebration, Florida, United States
        • Research Site
      • Fort Lauderdale, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Homestead, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Lehigh Acres, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Ormond Beach, Florida, United States
        • Research Site
      • Virginia Gardens, Florida, United States
        • Research Site
    • Georgia
      • Gainesville, Georgia, United States
        • Research Site
      • Smyrna, Georgia, United States
        • Research Site
    • Idaho
      • Eagle, Idaho, United States
        • Research Site
    • Illinois
      • Shiloh, Illinois, United States
        • Research Site
    • Kansas
      • Lenexa, Kansas, United States
        • Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States
        • Research Site
    • Maine
      • Bangor, Maine, United States
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States
        • Research Site
      • Flint, Michigan, United States
        • Research Site
      • Traverse City, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Missouri
      • St Louis, Missouri, United States
        • Research Site
    • Nevada
      • Las Vagas, Nevada, United States
        • Research Site
    • New Jersey
      • Union, New Jersey, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
      • Wilmington, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
      • Middleburg Heights, Ohio, United States
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    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Oregon
      • Corvallis, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Jefferson Hills, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
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    • South Carolina
      • Indian Land, South Carolina, United States
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Research Site
    • Texas
      • Arlington, Texas, United States
        • Research Site
      • Austin, Texas, United States
        • Research Site
      • Boerne, Texas, United States
        • Research Site
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
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      • San Antonio, Texas, United States
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    • Utah
      • Midvale, Utah, United States
        • Research Site
      • Murray, Utah, United States
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    • Virginia
      • Fairfax, Virginia, United States
        • Research Site
      • Falls Church, Virginia, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States
        • 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

Ages Eligible for Study

12 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
  3. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1.
  4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Exclusion criteria:

  1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:

    • Affect the safety of the patient throughout the study
    • Influence the findings of the studies or their interpretations
    • Impede the patient's ability to complete the entire duration of study
  3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
  4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the 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
Intervention / Treatment
Experimental: Benralizumab 30 mg q.4 weeks
Benralizumab administered subcutaneously every 4 weeks
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Experimental: Benralizumab 30 mg q.8 weeks
Benralizumab administered subcutaneously every 8 weeks
Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
Placebo Comparator: Placebo
Placebo administered subcutaneously
Placebo subcutaneously on study week 0 until study week 52 inclusive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.
Immediately following the first administration of study drug through Study Week 56.
Change in Asthma Rescue Medication Use
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)
Immediately following the first administration of study drug through Study Week 56.
Home Lung Function Assessments Based on PEF
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])
Immediately following the first administration of study drug through Study Week 56.
Proportion of Nights With Awakening Due to Asthma
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL
Time Frame: Immediately following the first administration of study drug through Study Week 56.
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.
Immediately following the first administration of study drug through Study Week 56.
Number of Patients With >=1 Asthma Exacerbation
Time Frame: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Time to First Asthma Exacerbation
Time Frame: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations
Time Frame: Immediately following the first administration of study drug through Study Week 56.
Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)
Immediately following the first administration of study drug through Study Week 56.
Pharmacokinetics of Benralizumab
Time Frame: Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Mean PK Concentration at each visit
Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60
Immunogenicity of Benralizumab
Time Frame: Pre-treatment until end of follow-up
Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Pre-treatment until end of follow-up
Extent of Exposure
Time Frame: Immediately following the first administration of study drug through Study Week 56
Extent of exposure is defined as the duration of treatment in days
Immediately following the first administration of study drug through Study Week 56
Mean Change From Baseline to Week 56 in AQLQ(S)+12
Time Frame: Immediately following the first administration of study drug through Study Week 56
AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.
Immediately following the first administration of study drug through Study Week 56
Change From Baseline to Week 56 in EQ-5D-5L VAS
Time Frame: Immediately following the first administration of study drug through Study Week 56
EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.
Immediately following the first administration of study drug through Study Week 56
Mean Work Productivity Loss Due to Asthma
Time Frame: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.
Immediately following the first administration of study drug through Study Week 56
Mean Productivity Loss Due to Asthma in Classroom
Time Frame: Immediately following the first administration of study drug through Study Week 56
WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.
Immediately following the first administration of study drug through Study Week 56
Number of Participants That Utilized Health Care Resources
Time Frame: Immediately following the first administration of study drug through Study Week 56
Immediately following the first administration of study drug through Study Week 56
Patient and Clinician Assessment of Response to Treatment
Time Frame: Immediately following the first administration of study drug through Study Week 56
CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.
Immediately following the first administration of study drug through Study Week 56

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Mark Fitzgerald, MD, PhD, Professor of Medicine, The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada

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

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

August 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

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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