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Trial record 1 of 1 for:    NCT01430403
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Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430403
First Posted: September 8, 2011
Last Update Posted: May 30, 2017
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. Read our disclaimer for details.
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: Omalizumab
Drug: Inhaled Corticosteroid Boost Therapy (ICS)
Biological: Placebo omalizumab
Biological: Placebo fluticasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eight National Institute of Allergy and Infectious Diseases (NIAID) Inner-City Asthma Consortium (ICAC) sites in the United States recruited the targeted number of study participants who fulfilled entry criteria. Recruitment occurred September 2011 to March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Omalizumab Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
Inhaled Corticosteroid Boost Therapy (ICS) Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
Placebo Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.

Participant Flow:   Overall Study
    Omalizumab   Inhaled Corticosteroid Boost Therapy (ICS)   Placebo
STARTED   259 [1]   130 [1]   89 [1] 
COMPLETED   242   121   81 
NOT COMPLETED   17   9   8 
Lost to Follow-up                5                5                3 
Physician Decision                1                0                0 
Protocol Violation                2                3                2 
Withdrawal by Subject                9                1                3 
[1] Intent-to-treat



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat

Reporting Groups
  Description
Omalizumab Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
Inhaled Corticosteroid Boost Therapy (ICS) Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
Placebo Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
Total Total of all reporting groups

Baseline Measures
   Omalizumab   Inhaled Corticosteroid Boost Therapy (ICS)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 259   130   89   478 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      259 100.0%      130 100.0%      89 100.0%      478 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age, Customized 
[Units: Participants]
       
6-11 years   190   102   67   359 
12-17 years   69   28   22   119 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      85  32.8%      60  46.2%      30  33.7%      175  36.6% 
Male      174  67.2%      70  53.8%      59  66.3%      303  63.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      88  34.0%      43  33.1%      30  33.7%      161  33.7% 
Not Hispanic or Latino      171  66.0%      87  66.9%      59  66.3%      317  66.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      5   1.9%      2   1.5%      2   2.2%      9   1.9% 
Asian      2   0.8%      0   0.0%      1   1.1%      3   0.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      152  58.7%      82  63.1%      57  64.0%      291  60.9% 
White      37  14.3%      18  13.8%      9  10.1%      64  13.4% 
More than one race      27  10.4%      12   9.2%      9  10.1%      48  10.0% 
Unknown or Not Reported      36  13.9%      16  12.3%      11  12.4%      63  13.2% 
Region of Enrollment 
[Units: Participants]
       
United States   259   130   89   478 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])   [ Time Frame: 90 Day outcome period ]

2.  Primary:   Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)   [ Time Frame: 90 Day outcome period ]

3.  Secondary:   Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples   [ Time Frame: 90 Day outcome period ]

4.  Secondary:   Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

5.  Secondary:   Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

6.  Secondary:   Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

7.  Secondary:   Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

8.  Secondary:   Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

9.  Secondary:   Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

10.  Secondary:   Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

11.  Secondary:   Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

12.  Secondary:   Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

13.  Secondary:   Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

14.  Secondary:   Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

15.  Secondary:   Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

16.  Secondary:   Work Disruptions Due to Child’s Asthma, Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

17.  Secondary:   Work Disruptions Due to Child’s Asthma, Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

18.  Secondary:   School Absences (Percent), Treatment Steps 2-5:Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

19.  Secondary:   School Absences (Percent), Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

20.  Secondary:   Percent Adherence to Asthma Medication, Treatment Steps 2-5: Omalizumab vs. Placebo   [ Time Frame: 90 Day outcome period ]

21.  Secondary:   Percent Adherence to Asthma Medication, Treatment Steps 2-4: Omalizumab vs. ICS   [ Time Frame: 90 Day outcome period ]

22.  Secondary:   Comparison of Home Allergen (Cockroach) Exposure and Asthma Exacerbations: Omalizumab Versus Placebo   [ Time Frame: 90 Day outcome period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications of Results:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01430403     History of Changes
Other Study ID Numbers: DAIT ICAC-20
First Submitted: September 1, 2011
First Posted: September 8, 2011
Results First Submitted: August 14, 2015
Results First Posted: September 16, 2015
Last Update Posted: May 30, 2017