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A Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Participants With Moderate to Severe Allergic Asthma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195958
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study will test the efficacy of omalizumab compared with placebo on exercise capacity, physical activity, and sleep quality after 24 weeks of treatment in participants with moderate to severe allergic asthma. Exercise capacity will be assessed using cardiopulmonary exercise testing (CPET). Physical activity and sleep quality will be assessed with a wearable physical activity and sleep monitor. The study will consist of a 4-week screening period, a 24-week double-blind treatment period, and a 4-week safety follow-up. Approximately 150 participants will be randomized at a 2:1 ratio to omalizumab and placebo, respectively.

Condition or disease Intervention/treatment Phase
Moderate-to-severe Allergic Asthma Drug: Omalizumab Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Impact of Omalizumab on Exercise Capacity, Physical Activity, and Sleep Quality in Patients With Moderate to Severe Allergic Asthma
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Omalizumab Drug: Omalizumab
Omalizumab will be administered by subcutaneous (SC) injection at a dose of 75 milligrams (mg) to 375 mg and dosing frequency every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured before the first dose of study treatment.

Placebo Comparator: Placebo Drug: Placebo
Matching placebo will be administered by SC injection every 2 to 4 weeks based on body weight (kg) and the level of total IgE (IU/mL) measured before the first dose of study treatment.




Primary Outcome Measures :
  1. Change from Baseline at Week 24 in Endurance Time (Minutes) During Cardiopulmonary Exercise Testing (CPET) at a Constant Work Rate (CWR) [ Time Frame: From Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Change from Baseline at Week 24 in Physical Activity (Minutes/Day) as Assessed by a Wearable Physical Activity and Sleep Monitor [ Time Frame: From Baseline to Week 24 ]
  2. Change from Baseline at Week 24 in Dynamic Hyperinflation at Isotime, as Measured by Inspiratory Capacity During CPET at a CWR [ Time Frame: From Baseline to Week 24 ]
  3. Change from Baseline at Week 24 in Sleep Efficiency as Assessed by a Wearable Physical Activity and Sleep Monitor [ Time Frame: From Baseline to Week 24 ]
  4. Incidence of Adverse Events [ Time Frame: From Baseline to Week 28 ]
  5. Incidence of Serious Adverse Events [ Time Frame: From Baseline to Week 28 ]
  6. Incidence of Adverse Events Leading to Discontinuation of Omalizumab or Placebo [ Time Frame: From Baseline to Week 24 ]


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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician-diagnosed allergic asthma for at least 12 months prior to screening
  • Documented history of positive skin test or in vitro reactivity to a perennial aeroallergen
  • Able to comply with asthma control medication adherence, digital monitoring data collection, and eDiary requirements during screening period
  • Able to safely complete incremental exercise tolerance at screening
  • Pre-bronchodilator FEV1 of 40%-80% of predicted at screening
  • Documented history of variable airflow obstruction or hyper-responsiveness within 12 months of study entry
  • On inhaled corticosteroids (ICS) therapy at a total daily dose greater than or equal to (≥)500 micrograms (ug) of fluticasone propionate or equivalent and at least one second controller (LABA, LAMA, LTRA) for ≥3 months prior to screening
  • Uncontrolled asthma during the screening period, defined as an ACQ-5 ≥0.75 score
  • Sleep disturbance due to asthma (e.g. cough, wheezing etc.) in the opinion of the investigator

Exclusion Criteria:

  • Known history of anaphylaxis/hypersensitivity to omalizumab
  • Treatment with investigational drugs within 12 weeks or 5 half-lives (whichever is longer) prior to screening
  • Treatment with monoclonal antibodies (e.g., omalizumab, mepolizumab, dupilumab) for 6 months prior to screening
  • Maintenance oral corticosteroid therapy, defined as daily or alternate-day oral corticosteroid within 3 months prior to screening or during the screening period
  • Treatment with systemic (oral, IV, or IM) corticosteroids within 4 weeks prior to screening or during the screening period
  • Isolated diagnosis of exercise induced asthma without chronic symptoms
  • History of interstitial lung disease, COPD, or other clinically significant lung disease other than asthma
  • Current malignancy or history of malignancy within 5 years prior to screening
  • Unable to complete cardiopulmonary exercise testing and/or perform physical activity due to underlying cardiac, neurologic or orthopedic conditions
  • Known sleep disorder diagnosis, including sleep apnea
  • Current smoker or past smoker with >10 pack years
  • Known HIV infection at screening
  • Known acute or chronic infections with hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening
  • Infection that resulted in hospital admission, required treatment with intravenous or intramuscular antibiotics within 4 weeks prior to screening, or any active infection that required treatment with oral antibiotics within 2 weeks prior to screening
  • Active tuberculosis requiring treatment within 12 months prior to screening
  • History of alcohol, drug, or chemical abuse within 6 months of screening

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): NCT04195958


Contacts
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Contact: Reference Study ID Number: ML41615 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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United States, California
Eisenhower Medical Center Not yet recruiting
Rancho Mirage, California, United States, 92270
United States, Colorado
Asthma & Allergy; Associates, P.C. Not yet recruiting
Colorado Springs, Colorado, United States, 80907
National Jewish Health Not yet recruiting
Denver, Colorado, United States, 80206
United States, Illinois
Northshore Sys Medical Group Not yet recruiting
Glenview, Illinois, United States, 60025
United States, Iowa
University of Iowa Hospitals & Clinics; Internal Medicine Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, Maine
Dr. Paul Shapero Not yet recruiting
Bangor, Maine, United States, 04401
United States, Michigan
University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology Not yet recruiting
Ann Arbor, Michigan, United States, 48109
United States, Montana
Great Falls Clinic; Clinical Research Department Not yet recruiting
Great Falls, Montana, United States, 59405
United States, North Carolina
American Health Research Inc. Not yet recruiting
Charlotte, North Carolina, United States, 28207
United States, Ohio
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44016
United States, Pennsylvania
Temple Uni Medical Center; Pulmonary & Critical Care Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Washington
Swedish Health Services Not yet recruiting
Seattle, Washington, United States, 98122
The Vancouver Clinic; Research Department Not yet recruiting
Vancouver, Washington, United States, 98664-4896
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04195958    
Other Study ID Numbers: ML41615
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).


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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
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs