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The ACCP Clinical Trials Registry is a free service that helps connect physicians and their patients with ongoing clinical trials in respiratory disease being conducted by participating pharmaceutical companies. Participation in clinical trials provides an opportunity to advance and accelerate medical research and contribute to improved and effective care for patients.
The following is a list of industry clinical trials available on the ACCP website at chestnet.org/About-ACCP/Industry-Support/ACCP-Clinical-Trials-Registry.
PROSPERO
A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab
Company: Genentech, Inc.
Clinical trial description: The PROSPERO registry is a prospective, observational study designed to examine baseline patient characteristics, including biomarkers, and to evaluate predictors of response to Xolair (omalizumab) treatment in patients with allergic asthma.
Type of patient needed: Patients who are 12 years of age or greater who are initiating treatment with omalizumab for allergic asthma and who have not been treated with omalizumab within the previous year.
Posted: October 11, 2013
ClinicalTrials.gov Identifier: NCT01867125
LAVOLTA I and LAVOLTA II
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Company: Genentech, Inc.
Clinical trial description: LAVOLTA I and LAVOLTA II are two parallel phase III studies designed to evaluate the efficacy and safety of lebrikizumab in patients with uncontrolled asthma despite treatment with an inhaled corticosteroid and a second controller medication.
Type of patient needed: Adult patients with asthma who continue to have symptoms after receiving treatment with an inhaled corticosteroid and a second controller medication for at least 6 months may be considered for these clinical trials.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01867125
RIFF
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis RIFF
Company: Genentech, Inc.
Clinical trial description: The phase II study (RIFF) is designed to evaluate the safety and efficacy of lebrikizumab in patients with idiopathic pulmonary fibrosis (IPF). The primary outcome measure for the study is progression free survival.
Type of patient needed: Adult patients = 40 years of age with a definite diagnosis of IPF according to the 2011 ATS/ERS/JRS/ALAT consensus statement on IPF within the previous 4 years from the time of screening.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01872689
EXPECT
The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Company: Genentech, Inc.
Clinical trial description:The Xolair Pregnancy Registry (EXPECT) is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair® (omalizumab) during their pregnancy.
Type of patient needed: Women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.
Additional information: Pregnancy Category B. There are no adequate and well-controlled studies of Xolair in pregnant women.
Posted: May 14, 2013
ClinicalTrials.gov Identifier: NCT00373061
The ACCP Clinical Trials Registry is a free service that helps connect physicians and their patients with ongoing clinical trials in respiratory disease being conducted by participating pharmaceutical companies. Participation in clinical trials provides an opportunity to advance and accelerate medical research and contribute to improved and effective care for patients.
The following is a list of industry clinical trials available on the ACCP website at chestnet.org/About-ACCP/Industry-Support/ACCP-Clinical-Trials-Registry.
PROSPERO
A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab
Company: Genentech, Inc.
Clinical trial description: The PROSPERO registry is a prospective, observational study designed to examine baseline patient characteristics, including biomarkers, and to evaluate predictors of response to Xolair (omalizumab) treatment in patients with allergic asthma.
Type of patient needed: Patients who are 12 years of age or greater who are initiating treatment with omalizumab for allergic asthma and who have not been treated with omalizumab within the previous year.
Posted: October 11, 2013
ClinicalTrials.gov Identifier: NCT01867125
LAVOLTA I and LAVOLTA II
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Company: Genentech, Inc.
Clinical trial description: LAVOLTA I and LAVOLTA II are two parallel phase III studies designed to evaluate the efficacy and safety of lebrikizumab in patients with uncontrolled asthma despite treatment with an inhaled corticosteroid and a second controller medication.
Type of patient needed: Adult patients with asthma who continue to have symptoms after receiving treatment with an inhaled corticosteroid and a second controller medication for at least 6 months may be considered for these clinical trials.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01867125
RIFF
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis RIFF
Company: Genentech, Inc.
Clinical trial description: The phase II study (RIFF) is designed to evaluate the safety and efficacy of lebrikizumab in patients with idiopathic pulmonary fibrosis (IPF). The primary outcome measure for the study is progression free survival.
Type of patient needed: Adult patients = 40 years of age with a definite diagnosis of IPF according to the 2011 ATS/ERS/JRS/ALAT consensus statement on IPF within the previous 4 years from the time of screening.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01872689
EXPECT
The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Company: Genentech, Inc.
Clinical trial description:The Xolair Pregnancy Registry (EXPECT) is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair® (omalizumab) during their pregnancy.
Type of patient needed: Women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.
Additional information: Pregnancy Category B. There are no adequate and well-controlled studies of Xolair in pregnant women.
Posted: May 14, 2013
ClinicalTrials.gov Identifier: NCT00373061
The ACCP Clinical Trials Registry is a free service that helps connect physicians and their patients with ongoing clinical trials in respiratory disease being conducted by participating pharmaceutical companies. Participation in clinical trials provides an opportunity to advance and accelerate medical research and contribute to improved and effective care for patients.
The following is a list of industry clinical trials available on the ACCP website at chestnet.org/About-ACCP/Industry-Support/ACCP-Clinical-Trials-Registry.
PROSPERO
A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab
Company: Genentech, Inc.
Clinical trial description: The PROSPERO registry is a prospective, observational study designed to examine baseline patient characteristics, including biomarkers, and to evaluate predictors of response to Xolair (omalizumab) treatment in patients with allergic asthma.
Type of patient needed: Patients who are 12 years of age or greater who are initiating treatment with omalizumab for allergic asthma and who have not been treated with omalizumab within the previous year.
Posted: October 11, 2013
ClinicalTrials.gov Identifier: NCT01867125
LAVOLTA I and LAVOLTA II
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Company: Genentech, Inc.
Clinical trial description: LAVOLTA I and LAVOLTA II are two parallel phase III studies designed to evaluate the efficacy and safety of lebrikizumab in patients with uncontrolled asthma despite treatment with an inhaled corticosteroid and a second controller medication.
Type of patient needed: Adult patients with asthma who continue to have symptoms after receiving treatment with an inhaled corticosteroid and a second controller medication for at least 6 months may be considered for these clinical trials.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01867125
RIFF
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis RIFF
Company: Genentech, Inc.
Clinical trial description: The phase II study (RIFF) is designed to evaluate the safety and efficacy of lebrikizumab in patients with idiopathic pulmonary fibrosis (IPF). The primary outcome measure for the study is progression free survival.
Type of patient needed: Adult patients = 40 years of age with a definite diagnosis of IPF according to the 2011 ATS/ERS/JRS/ALAT consensus statement on IPF within the previous 4 years from the time of screening.
Additional information: Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013
ClinicalTrials.gov Identifier: NCT01872689
EXPECT
The Xolair Pregnancy Registry: An Observational Study of the Use and Safety of Xolair® (Omalizumab) During Pregnancy
Company: Genentech, Inc.
Clinical trial description:The Xolair Pregnancy Registry (EXPECT) is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair® (omalizumab) during their pregnancy.
Type of patient needed: Women who have been exposed to at least one dose of Xolair within 8 weeks prior to conception or during pregnancy may be included in this registry.
Additional information: Pregnancy Category B. There are no adequate and well-controlled studies of Xolair in pregnant women.
Posted: May 14, 2013
ClinicalTrials.gov Identifier: NCT00373061
