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)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Typically, people with asthma are initially prescribed a low dose of inhaled corticosteroid (ICS) medication to control asthma symptoms. If a low dose of ICS is ineffective at controlling symptoms, the addition of a second controller medication is recommended. This study will examine the effectiveness of the medication tiotropium bromide combined with a low dose of ICS at maintaining asthma control in people with moderately severe asthma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Beclomethasone; Bromides; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

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:

1. Beta-agonist reversibility to 4 puffs albuterol of at least 12% OR

2. 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:

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 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.)