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. 2015 Jul 22;2015(7):CD011032. doi: 10.1002/14651858.CD011032.pub2

Martinez 2011.

Methods Design: 44‐week, randomised, double‐blind, placebo‐controlled trial
Setting: 5clinical centres in the USA: Denver, CO; Madison, WI; Saint Louis, MO; San Diego, CA; and Tucson, AZ (satellite centres in Milwaukee, WI, and Albuquerque, NM, also recruited participants).
Date of study: January 2007 to May 2009
Participants Participants: n = 288 (58 received rescue beclomethasone: 50 received placebo)
Baseline characteristics: mean age (intermittent ICS: 10.4 years, placebo 10.4 years; range 5‐18 years); gender ‐ male (intermittent ICS 52%, placebo 55%); mean % predicted FEV1 (intermittent ICS 101.4%, placebo 100.4%); mean asthma history (mild persistent asthma during previous 2 years); mean daily dose of inhaled corticosteroids (not stated); rescue medication (intermittent ICS 0.4, placebo 0.5 puffs/day).
Diagnostic criteria: US National Asthma Education and Prevention Program asthma care guidelines
Asthma severity: mild persistent
Inclusion criteria: Naive to controller treatment and history of one to two exacerbations in previous year, if treated for previous 8 weeks with monotherapy other than inhaled corticosteroids, if illness was controlled for the previous 8 weeks on low‐dose corticosteroids as monotherapy. No exacerbations during run in period.
Exclusion criteria: pre‐bronchodilator forced expiratory volume in 1 s (FEV1) of less than 60% predicted at the first visit; admitted to hospital for asthma in previous year; asthma exacerbation in the previous 3 months or more than two in previous year; history of life‐threatening asthma exacerbations that required intubation or mechanical ventilation, or that resulted in a hypoxic seizure.
Interventions Run‐in period: twice daily treatment with one puff of beclomethasone dipropionate and rescue treatment with a placebo inhaler added to rescue albuterol every time they needed albuterol.
Interventions:
1. twice daily placebo with beclomethasone plus albuterol as rescue (rescue beclomethasone group); and
2. twice daily placebo with placebo plus albuterol as rescue (placebo group)
Concomitant medication
Nil
Outcomes Primary outcome(s): time to first exacerbation that required treatment with prednisone
Secondary outcome(s):

  1. spirometry FEV1;

  2. fractional exhaled nitric oxide (FeNO);

  3. symptom diaries;

  4. control and quality of life questionnaires;

  5. linear growth.


Criteria for assigning treatment failure during treatment period.
 a. Hospitalization due to asthma.
 b. Hypoxic seizure due to asthma.
 c. Intubation due to asthma.
 d. Requirement for a second burst of prednisone within any 6 month period.
 e. Significant adverse event related to the use of a study medication.
 The only criterion for assignment of treatment failure during the trial was the requirement for a second burst of prednisone within any 6 month period.
Notes Funding: this study was funded by National Heart, Lung and Blood Institute.
Clinicaltrials.gov study code NCT00394329
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The Data Coordinating Center (DCC; Penn State Hershey College, PA, USA) generated the random allocation sequence.
Allocation concealment (selection bias) Low risk When a clinical centre deemed that a participant was eligible for randomisation, the clinical centre coordinator logged onto the secure CARE Network website, entered the relevant information to confirm participant eligibility, and received the appropriate drug packet code to be assigned to the participant.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Drug groups were labelled as A, B, C, and D to mask statisticians to treatment group during the first complete run‐through of data analyses.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The DCC had no interaction with participants,but was responsible for management of data and statistical analyses.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk May tend to underestimate results. 13 withdrawals (out of 71) in the intermittent ICS group, compared with 24 (out of 74) in the placebo group. A greater number, 17 of treatment failures in the placebo group compared with 6 in the intermittent ICS group
Selective reporting (reporting bias) Low risk All outcomes reported
Other bias Low risk Nil identified