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Study of Asthma and Nasal Steroids (STAN)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier:
NCT01118312
First received: April 28, 2010
Last updated: October 29, 2015
Last verified: October 2015
Results First Received: September 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: Asthma
Rhinitis
Sinusitis
Interventions: Drug: Mometasone Furoate monohydrate
Other: Placebo

  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
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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
Nasal Steroid

Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day

Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months

Placebo

Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day

Placebo: Intranasal placebo spray


Participant Flow:   Overall Study
    Nasal Steroid   Placebo
STARTED   189   199 
COMPLETED   155   164 
NOT COMPLETED   34   35 
Lost to Follow-up                33                32 
Withdrawal by Subject                1                3 



  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.
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Reporting Groups
  Description
Nasal Steroid

Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day

Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months

Placebo

Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day

Placebo: Intranasal placebo spray

Total Total of all reporting groups

Baseline Measures
   Nasal Steroid   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 189   199   388 
Age 
[Units: Participants]
     
<=18 years   72   79   151 
Between 18 and 65 years   117   120   237 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   105   106   211 
Male   84   93   177 


  Outcome Measures
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1.  Primary:   Asthma Control Test (ACT)   [ Time Frame: 24 weeks ]

2.  Secondary:   Childhood Asthma Control Test   [ Time Frame: 24 weeks ]


  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: Razan Yasin
Organization: Johns Hopkins University
phone: 443-287-5796
e-mail: ryasin1@jhu.edu



Responsible Party: JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier: NCT01118312     History of Changes
Other Study ID Numbers: ALAACRC-11
R01 HL089464-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL00895101-01A2 ( Other Identifier: NIH/NHLBI )
Study First Received: April 28, 2010
Results First Received: September 24, 2015
Last Updated: October 29, 2015