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Study of Asthma and Nasal Steroids (STAN)

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.
 
ClinicalTrials.gov Identifier: NCT01118312
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
JHSPH Center for Clinical Trials

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Asthma
Rhinitis
Sinusitis
Interventions Drug: Mometasone Furoate monohydrate
Other: Placebo
Enrollment 388
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nasal Steroid Placebo
Hide Arm/Group Description

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

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

Placebo: Intranasal placebo spray

Period Title: Overall Study
Started 189 199
Completed 155 164
Not Completed 34 35
Reason Not Completed
Lost to Follow-up             33             32
Withdrawal by Subject             1             3
Arm/Group Title Nasal Steroid Placebo Total
Hide Arm/Group Description

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

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

Placebo: Intranasal placebo spray

Total of all reporting groups
Overall Number of Baseline Participants 189 199 388
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 199 participants 388 participants
<=18 years
72
  38.1%
79
  39.7%
151
  38.9%
Between 18 and 65 years
117
  61.9%
120
  60.3%
237
  61.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 199 participants 388 participants
Female
105
  55.6%
106
  53.3%
211
  54.4%
Male
84
  44.4%
93
  46.7%
177
  45.6%
1.Primary Outcome
Title Asthma Control Test (ACT)
Hide Description Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of adult (18 and above) Asthma Control Scores
Arm/Group Title Nasal Steroid Placebo
Hide Arm/Group Description:

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

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

Placebo: Intranasal placebo spray

Overall Number of Participants Analyzed 117 120
Mean (Standard Error)
Unit of Measure: units on a scale
2.95  (0.31) 2.44  (0.38)
2.Secondary Outcome
Title Childhood Asthma Control Test
Hide Description Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Children (less than 18 years old) Childhood Asthma Control Test scores
Arm/Group Title Nasal Steroid Placebo
Hide Arm/Group Description:

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

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

Placebo: Intranasal placebo spray

Overall Number of Participants Analyzed 72 79
Mean (Standard Error)
Unit of Measure: units on a scale
4.15  (0.64) 4.53  (0.65)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nasal Steroid Placebo
Hide Arm/Group Description

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

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

Placebo: Intranasal placebo spray

All-Cause Mortality
Nasal Steroid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Nasal Steroid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/189 (1.06%)   9/199 (4.52%) 
General disorders     
Anaphylactic reaction  1/189 (0.53%)  0/199 (0.00%) 
Dental abscess  0/189 (0.00%)  1/199 (0.50%) 
Dehydration  0/189 (0.00%)  1/199 (0.50%) 
Infections and infestations     
pneumonia  0/189 (0.00%)  1/199 (0.50%) 
appendicitis  0/189 (0.00%)  1/199 (0.50%) 
Psychiatric disorders     
Depression (hospitalized)  1/189 (0.53%)  1/199 (0.50%) 
Respiratory, thoracic and mediastinal disorders     
asthma exacerbation  0/189 (0.00%)  2/199 (1.01%) 
Surgical and medical procedures     
Fungus ball of the sinus requiring surgery  0/189 (0.00%)  1/199 (0.50%) 
Vascular disorders     
Headache and high blood pressure  0/189 (0.00%)  1/199 (0.50%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nasal Steroid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   105/179 (58.66%)   127/187 (67.91%) 
Ear and labyrinth disorders     
Dizzy  [1]  9/172 (5.23%)  17/181 (9.39%) 
General disorders     
Sore throat  [1]  22/174 (12.64%)  34/175 (19.43%) 
Nasal bleed  [1]  10/176 (5.68%)  15/184 (8.15%) 
Nasal pain  [1]  25/162 (15.43%)  44/168 (26.19%) 
Swelling  [1]  10/175 (5.71%)  19/183 (10.38%) 
Infections and infestations     
Upper respiratory tract infection  [1]  27/178 (15.17%)  28/184 (15.22%) 
Reproductive system and breast disorders     
Dysmenorrhea  [1]  10/116 (8.62%)  14/112 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Trouble breathing  [1]  42/136 (30.88%)  55/152 (36.18%) 
Cough  [1]  39/133 (29.32%)  44/157 (28.03%) 
Skin and subcutaneous tissue disorders     
Rash  [1]  7/172 (4.07%)  18/180 (10.00%) 
Itching  [1]  17/157 (10.83%)  23/165 (13.94%) 
Vascular disorders     
Headache  [1]  45/140 (32.14%)  56/148 (37.84%) 
Indicates events were collected by systematic assessment
[1]
Counts include the number of individuals who experienced a moderate or severe symptom at follow up. Individuals who had the symptom (moderate or severe) at baseline are excluded as are those with no follow-up data on the adverse event.
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
Layout table for Results Point of Contact information
Name/Title: Razan Yasin
Organization: Johns Hopkins University
Phone: 443-287-5796
EMail: ryasin1@jhu.edu
Layout table for additonal information
Responsible Party: JHSPH Center for Clinical Trials
ClinicalTrials.gov Identifier: NCT01118312    
Other Study ID Numbers: ALAACRC-11
R01 HL089464-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL00895101-01A2 ( Other Identifier: NIH/NHLBI )
First Submitted: April 28, 2010
First Posted: May 6, 2010
Results First Submitted: September 24, 2015
Results First Posted: November 30, 2015
Last Update Posted: November 30, 2015