Asthma Clinical Research Network (ACRN) Trial - Best Adjustment Strategy for Asthma in Long Term (BASALT)
Condition: Asthma
MeSH terms: Asthma
Intervention: Symptom-based adjustment; Biomarker-based adjustment; Guideline-based adjustment
Intervention description: Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg); Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg); Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 342.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Asthma can be effectively controlled using inhaled corticosteroid medication. Treatment with
      inhaled corticosteroids often requires periodic adjustments to medication dosing and
      frequency levels. This study examines whether it is more beneficial to adjust corticosteroid
      treatment based on asthma symptoms and/or biomarkers of lung function versus standard medical
      guidelines.
    

Eligibility criteria:

        Inclusion Criteria for BASALT and TALC Studies:

          -  Clinical history consistent with asthma

          -  Forced expiratory volume in one second (FEV1) greater than 40% of predicted value

          -  Asthma confirmed by one of the following two criteria:

               1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR

               2. Methacholine provocative concentration at 20% (PC20) FEV1 of 8 milligrams per
                  millimeter (mg/mL) or less when not on an inhaled corticosteroid, or 16 mg/mL or
                  less when on an inhaled corticosteroid

          -  Need for daily controller therapy (i.e., inhaled corticosteroids, leukotriene
             modifiers, and/or long-acting beta-agonists) based on one or more of the following
             criteria:

               1. Received prescription for or used asthma controller within the 12 months prior to
                  study entry OR

               2. Experienced symptoms for more than twice a week and not on asthma controller

          -  If on inhaled steroids (any drug at any dose not exceeding the equivalent of 1000
             micrograms (mcg) of fluticasone daily), participant must have been on a stable dose
             for at least 2 weeks prior to study entry

          -  Non-smoker (i.e., total lifetime smoking history less than 10 pack-years; no smoking
             for at least 1 year prior to study entry)

          -  Willing to use an effective form of birth control throughout the study

        Inclusion Criteria for BASALT Study:

          -  Ability to measure peak expiratory flow (PEF) each morning using the electronic peak
             flow meter (EPFM) device and to accurately transcribe the PEF measurements onto the
             diary cards at least 75% of the time during the last 2 weeks of the adherence testing
             period

          -  75% compliance with recording peak flow measurements and symptoms in a symptom diary
             during the last 2 weeks of the adherence testing period

          -  Ability to take Inhalers A, B, and C at least 75% of scheduled doses; 75% compliance
             per inhaler is required

          -  No treatment failure (includes significant asthma exacerbation) within the last 4
             weeks

        Exclusion Criteria for BASALT and TALC Studies:

          -  Lung disease other than asthma, including chronic obstructive pulmonary disease (COPD)
             and chronic bronchitis

          -  Established or suspected diagnosis of vocal cord dysfunction

          -  Significant medical illness other than asthma

          -  History of respiratory tract infection within the 4 weeks prior to study entry

          -  History of a significant exacerbation of asthma within the 4 weeks prior to study
             entry

          -  History of life-threatening asthma requiring treatment with intubation and mechanical
             ventilation in the 5 years prior to study entry

          -  Hyposensitization therapy other than an established maintenance regimen

          -  Inability to coordinate use of the delivery devices used in the study, based on the
             opinion of the investigator or clinical coordinator

          -  Pregnant

        Exclusion Criteria for BASALT Study:

          -  Inability to coordinate use of the medication delivery devices used in the study,
             based on the opinion of the investigator or clinical coordinator