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Lansoprazole to Treat Children With Asthma (SARCA)

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ClinicalTrials.gov Identifier: NCT00442013
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborators:
American Lung Association Asthma Clinical Research Centers
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Janet Holbrook, Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Lansoprazole
Drug: Matching placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Conducted from April 2007 to April 2011

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
Lansoprazole Group 15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
Placebo Group Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal

Participant Flow:   Overall Study
    Lansoprazole Group   Placebo Group
STARTED   157   149 
COMPLETED   131   132 
NOT COMPLETED   26   17 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Lansoprazole Group 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
Placebo Group Matching placebo
Total Total of all reporting groups

Baseline Measures
   Lansoprazole Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 157   149   306 
Age 
[Units: Participants]
     
<=18 years   157   149   306 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 11  (3)   11  (3)   11  (3) 
Gender 
[Units: Participants]
     
Female   55   63   118 
Male   102   86   188 
Region of Enrollment 
[Units: Participants]
     
United States   157   149   306 


  Outcome Measures

1.  Primary:   Change in Juniper Asthma Control Score (ACS)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 24 ]

2.  Secondary:   Asthma-specific Quality of Life   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

3.  Secondary:   Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

4.  Secondary:   Rate of Episodes of Poor Asthma Control (EPAC)   [ Time Frame: Measured daily for 24 weeks by diary ]

5.  Secondary:   Asthma Symptom Utility Index (ASUI)   [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ]

6.  Secondary:   Airways Reactivity (Assessed by Methacholine PC20)   [ Time Frame: Measured at Weeks 0 and 24 ]


  Serious Adverse Events


  Other Adverse Events

Time Frame 24 weeks
Additional Description Adverse event reported at study visits after randomization. Only participants completing at least on follow-up medical history form are included,

Frequency Threshold
Threshold above which other adverse events are reported   2%  

Reporting Groups
  Description
Lansoprazole Group 15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
Placebo Group Matching placebo

Other Adverse Events
    Lansoprazole Group   Placebo Group
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   93/147 (63.27%)   78/150 (52.00%) 
Ear and labyrinth disorders     
Otitis media     
# participants affected / at risk   12/147 (8.16%)   10/150 (6.67%) 
Infections and infestations     
upper respiratory infection     
# participants affected / at risk   93/147 (63.27%)   74/150 (49.33%) 
Group A streptococcus     
# participants affected / at risk   6/147 (4.08%)   11/150 (7.33%) 
Respiratory, thoracic and mediastinal disorders     
Sore throat     
# participants affected / at risk   77/147 (52.38%)   59/150 (39.33%) 
Bronchitis     
# participants affected / at risk   10/147 (6.80%)   3/150 (2.00%) 
Pneumonia     
# participants affected / at risk   4/147 (2.72%)   5/150 (3.33%) 
Acute sinusitis     
# participants affected / at risk   16/147 (10.88%)   17/150 (11.33%) 
* Events were collected by non-systematic assessment



  Limitations and Caveats

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
Results limited to patients without overt Gastroesophageal reflux disease(GERD). Did not conduct on-treatment potential hydrogen(pH) probe studies to confirm treatment effect. Protein-pump inhibitors(PPI) dose may not induce maximal acid suppression.


  More Information