Clinical trial NCT00394329 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: beclomethasone dipropionate, beclomethasone dipropionate, albuterol sulfate
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [Na+].[Cl-]
Eligibility criteria:

        Inclusion Criteria:

          -  Able to perform reproducible spirometry according to American Thoracic Society (ATS)
             criteria

          -  History of asthma symptoms that are adequately controlled in the 4 weeks prior to
             study entry, and meets at least one of the following criteria:

               1. History of mild persistent asthma symptoms (on average greater than 2 days per
                  week with symptoms or albuterol use for symptoms or greater than 2 night-time
                  awakenings per month during the year prior to study entry) and has been treated
                  with a single-controller inhaled corticosteroid (ICS) dose less than or equal to
                  160 mcg per day of a beclomethasone-equivalent or a leukotriene receptor
                  antagonist (LTRA) (in an age-appropriate dose) for the 4 weeks prior to study
                  entry; individuals treated with a combination controller therapy (e.g. ICS+LTRA
                  or ICS+long-acting beta-agonist (LABA)) in the past 8 weeks will not be eligible

               2. Not currently being treated with ICS, a history of mild persistent asthma, and 1
                  to 2 exacerbations in the year prior to study entry (but none in the 3 months
                  prior to study entry)

          -  Forced expiratory volume in one second (FEV1) reversibility of greater than or equal
             to 12% following bronchodilator administration (4 puffs); individuals who do not meet
             this requirement may qualify for enrollment if their methacholine provocative
             concentration at 20% (PC20) is less than or equal to 12.5 milligrams per milliliter
             (mg/ml)

          -  History of clinical varicella or varicella vaccine; individuals needing the vaccine
             may receive it from their primary care physician prior to study entry

          -  Ability of parent to provide informed consent; verbal assent must be obtained from
             children less than 7 years of age and written assent must be obtained from children
             between 7 and 18 years of age

          -  If female, willing to use an effective form of contraception

        Participants will be eligible for the 44 weeks of treatment if, after the 4-week screening
        period, their asthma remains controlled, and they demonstrate at least 80% predicted
        pre-bronchodilator FEV1. Participants must meet ALL of the criteria stated below during the
        8-week screening period to continue in the study:

          -  Meets the definition of acceptable asthma control, which is NOT having one or more of
             the following during ANY 2-week period:

               1. On average, on more than 2 days per week, experiences one or more of the
                  following:

                    1. Diary-reported symptoms

                    2. The use of inhaled bronchodilator (not including pre-exercise)

                    3. Peak flows in the yellow zone (less than 80% of personal best defined as
                       based on peak expiratory flow (PEF) value obtained at study visit 1

               2. More than 1 night-time awakening due to asthma

          -  Demonstrates adherence with taking study medications (at least 75% of scheduled
             doses), rescue medications (using both rescue inhalers for at least 75% of rescue
             doses), and completing patient diaries (at least 75% of days)

          -  Pre-bronchodilator FEV1 greater than or equal to 80% predicted at study visits 2 and 3

          -  Agrees to not use a spacer with beclomethasone/placebo study and rescue medications

        NOTE: In January 2008, the Data and Safety Monitoring Board (DSMB) approved changes in the
        TREXA eligibility criteria, by which neither FEV1 reversibility ≥ 12% nor a participant's
        methacholine PC20 ≤ 12.5 mg/ml were required for randomization.

        Exclusion Criteria:

          -  Corticosteroid treatment for any condition prior to study entry within the following
             defined timepoints:

               1. Oral - Use within 2-week period of the screening visit

               2. Injectable - Use within 2-week period of the screening visit

               3. Nasal corticosteroids may be used at any time during the study at the discretion
                  of the study investigator or primary care physician

          -  Current or prior use of medications known to significantly interact with
             corticosteroid disposition (within a 2-week period of study visit 1), including but
             not limited to carbamazepine, erythromycin or other macrolide antibiotics,
             phenobarbital, phenytoin, rifampin, or ketoconazole

          -  Pre-bronchodilator FEV1 less than 60% predicted at study visit 1

          -  Any hospitalization for asthma in the year prior to study entry

          -  Presence of chronic or active lung disease other than asthma

          -  Significant medical illness other than asthma, including thyroid disease, diabetes
             mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical
             problems that could require oral corticosteroids during the study

          -  History of cataracts, glaucoma, or any other medical disorder associated with an
             adverse effect to corticosteroids

          -  Any asthma exacerbation in the past 3 months or more than 2 in the past year.

          -  History of a life-threatening asthma exacerbation requiring intubation, mechanical
             ventilation, or resulting in a hypoxic seizure

          -  History of adverse reactions to ICS preparations or any of its ingredients

          -  Receiving hyposensitization therapy other than an established maintenance regimen
             (continuous regimen for at least 3 months)

          -  Pregnant or breastfeeding

          -  Cigarette smoking or smokeless tobacco use in the year prior to study entry

          -  Refusal to consent to a genotype evaluation

          -  Current participation or participation within 1 month of study entry in another
             investigational drug trial

          -  Evidence that the family may be unreliable or nonadherent, or may move from the
             clinical center area before study completion