A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT) (EXACT)
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|ClinicalTrials.gov Identifier: NCT00096954|
Recruitment Status : Completed
First Posted : November 18, 2004
Results First Posted : December 8, 2011
Last Update Posted : June 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: omalizumab (Xolair) Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||333 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)|
|Actual Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Omalizumab (Xolair) administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks.
Drug: omalizumab (Xolair)
Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
Placebo Comparator: Placebo
Placebo administered in this study was either a minimum of 0.008 mg/kg/IgE [IU/mL] every 2 weeks or a minimum of 0.016 mg/kg/IgE [IU/mL] every 4 weeks.
The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
- Rate of Asthma Exacerbations Over the 24 Week Treatment Period [ Time Frame: Start of treatment to 24 weeks ]
A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group.
- Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period [ Time Frame: Start of treatment to 24 weeks ]The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.
- Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24 [ Time Frame: Baseline and 24 weeks ]
The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).
The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).
Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).
A negative change from baseline score indicates improvement.
- Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24 [ Time Frame: Baseline and 24 weeks ]
Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.
The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group.
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): NCT00096954
|Study Director:||Karin Rosen, MD, PhD||Genentech, Inc.|