Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)

Inclusion Criteria for TALC and BASALT 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:
• Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR
• Methacholine provocative concentration at 20% (PC20) of 8 milligrams per milliliter (mg/mL) or less when not on an inhaled corticosteroid (ICS), or 16 mg/mL or less when on an ICS
• Need for daily controller therapy (i.e., ICS, leukotriene modifiers, and/or long-acting beta-agonists) based on one or more of the following criteria:
• Received prescription for or used asthma controller within the 12 months prior to study entry OR
• 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 TALC Study:

• Ability to measure morning (AM) peak expiratory flow (PEF) on schedule using electronic peak flow meter (EPFM) and to complete the study diary correctly at least 75% of the time during the interval between Weeks 2 and 4 of the run-in period
• Adherence with study medication dosing at least 75% of the time during the interval between Weeks 2 and 4 of the run-in period
• No asthma exacerbation requiring use of oral corticosteroids or additional asthma medications (including an increased dose of ICS) during the run-in period
• FEV1 greater than 40% of the predicted value

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 asthma exacerbation 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 TALC Study:

• Inability to coordinate use of the medication delivery devices used in the study, based on the opinion of the investigator or clinical coordinator
• Presence at Week 4 of the run-in period of any of the exclusion criteria stipulated for Week 0 of the run-in period (Note: Respiratory tract infections that do not cause the participant to meet exacerbation criteria are not considered exclusionary.)