Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01508936
First received: January 3, 2012
Last updated: May 8, 2014
Last verified: May 2014

January 3, 2012
May 8, 2014
January 2012
August 2013   (final data collection date for primary outcome measure)
Change in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
Same as current
Complete list of historical versions of study NCT01508936 on ClinicalTrials.gov Archive Site
  • Change in FEV1 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in FEV1 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in FEV1 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the forced vital capacity (FVC).
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and 12 weeks after end of treatment (EOT) or early withdrawal ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Summary of participants with Adverse Events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Change in FEV1 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in FEV1 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in FEV1 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 will be measured using forced expiratory air spirometry. Standard methods for this measurement are widely accepted in clinical practice.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the forced vital capacity (FVC).
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Percent Predicted FEV1 [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the FVC.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Forced Expiratory Flow Rate (FEF) 25-75% [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    FEF 25-75% is the average forced expiratory flow rate during the middle portion of expiration.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in Beta-agonist use [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The number of times a beta-agonist therapy is used will be assessed using 3-day recall at scheduled visits. Patients will be asked to recall date and time of any use of beta-agonist therapy, name of medicine, and number of puffs inhaled.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in blood eosinophil count [ Time Frame: Baseline and 12 weeks after end of treatment (EOT) or early withdrawal ] [ Designated as safety issue: No ]
    The blood eosinophil counts will be measured using a standard complete blood count (CBC) with differential blood test. The results of the differential will be blinded.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 16 ] [ Designated as safety issue: No ]
    The ACQ is a validated asthma assessment tool that has been widely used. Six questions are self assessments; the seventh item is the result of the patient's FEV1 measurement. Each item on the ACQ has a possible score ranging from 0 (indicating that the asthma is well controlled) to 6 (indicating that the asthma is severely uncontrolled), and the total score is the mean of all responses.
Not Provided
Not Provided
 
Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma
A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Eosinophilic Asthma
  • Drug: Reslizumab
    Reslizumab will be administered to patients at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
  • Drug: Matching Placebo
    Matching placebo will be administered every 4 weeks for 16 weeks.
  • Experimental: Reslizumab
    Intervention: Drug: Reslizumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
October 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

Patients are included in the study if all of the following criteria are met:

  • The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.
  • The patient has an ACQ score of at least 1.5.
  • At screening, the patient has airway reversibility of at least 12% to beta-agonist administration.
  • The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening and continue without dosage changes throughout study.
  • Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test at screening (serum) and baseline (urine).
  • Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
  • Written informed consent is obtained.
  • The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology.
  • The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

  • The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
  • The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
  • The patient has known hypereosinophilic syndrome (HES).
  • The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
  • The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
  • The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
  • The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
  • The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease).
  • The patient has participated in any investigative drug or device study within 30 days prior to screening.
  • The patient has participated in any investigative biologics study within 90 days prior to screening.
  • The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
  • The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
  • The patient has a current infection or disease that may preclude assessment of asthma.
  • The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency).
  • The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
  • The patient has presence of or suspected parasitic infestation/infection.
  • Patients may not have received any live attenuated vaccine within the 12-week period before study entry.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508936
C38072/3084
Not Provided
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries
Not Provided
Study Director: Global Respiratory Clinical Research, M.D. Sponsor's Medical Expert
Teva Pharmaceutical Industries
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP