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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:
Collaborator:
Inner-City Asthma Consortium
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01430403
First received: September 1, 2011
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Biological: Omalizumab+Conventional Therapy
Drug: Fluticasone+Conventional Therapy
Biological: Placebo omalizumab+Conventional Therapy
Biological: Placebo fluticasone+Conventional Therapy

  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
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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]
       
<=18 years   259   130   89   478 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Age, Customized 
[Units: Participants]
       
6-11 years   190   102   67   359 
12-17 years   69   28   22   119 
Gender 
[Units: Participants]
       
Female   85   60   30   175 
Male   174   70   59   303 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   88   43   30   161 
Not Hispanic or Latino   171   87   59   317 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   5   2   2   9 
Asian   2   0   1   3 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   152   82   57   291 
White   37   18   9   64 
More than one race   27   12   9   48 
Unknown or Not Reported   36   16   11   63 
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:   Composite Asthma Severity Index (CASI), Treatment Steps 2-5 (Omalizumab vs. Placebo)   [ Time Frame: 90 Day outcome period ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

19.  Secondary:   Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples   [ Time Frame: 4-5 month ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   Yes

20.  Secondary:   Severity of Asthma Symptoms Associated With a Viral Infection   [ Time Frame: 4-5 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   Yes

21.  Secondary:   Number of Exacerbations Evaluated Monthly With and Without Viral Respiratory Infections   [ Time Frame: 4-5 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   Yes

22.  Secondary:   Home Allergen Levels   [ Time Frame: 4-5 months ]
Results not yet reported.   Anticipated Reporting Date:   08/2016   Safety Issue:   No


  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
Study First Received: September 1, 2011
Results First Received: August 14, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration