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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00565266 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Tiotropium bromide Drug: Salmeterol xinofoate Drug: Beclomethasone dipropionate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Active Control, Crossover Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized, Safety/Efficacy Study, Treatment |
| Official Title: | 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) |
| Estimated Enrollment: | 224 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
|
2: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
|
3: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
|
6: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
|
5: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
|
4: Experimental
Participants will take part in three 16-week treatment periods, which will occur in the following order:
Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. |
Drug: Tiotropium bromide
Tiotropium bromide inhalation powder (SPIRIVA® HandiHaler®)
Drug: Salmeterol xinofoate
Salmeterol xinofoate inhalation powder bid (Serevent® Diskus® 50 mcg)
Drug: Beclomethasone dipropionate
Beclomethasone dipropionate 80 mcg bid or 160 mcg bid (QVAR® Inhalation Aerosol)
|
National and international asthma treatment guidelines recommend ICS as the initial controller therapy for people with asthma who are in need of daily treatment with a controller medication. If treatment with low to moderate doses of ICS is not sufficient to gain and maintain asthma control, current guidelines recommend adding a second controller medication rather than increasing the dose of ICS. Current options for the second medication include a long-acting beta-agonist, a leukotriene modifier, or theophylline. It is possible that other medications, not yet tested, could fill the role of the second controller medication. Tiotropium bromide is a medication that is used to treat chronic obstructive pulmonary disease (COPD). It works by relaxing and opening the air passages to the lungs to make breathing easier. For people with asthma, the addition of tiotropium bromide may be a good option as a second controller medication. The purpose of this study is to determine if combining tiotropium bromide with a low dose of ICS is more effective than doubling the dose of ICS in people with moderately severe asthma. This study will also examine whether the addition of tiotropium bromide to low dose ICS is as effective as the addition of a long-acting beta-agonist at maintaining asthma control.
This study will begin with a 4-week run-in period during which participants will be monitored while they use an inhaler containing a low dose of ICS medication. Next, participants will be assigned to take part in either the TALC study or the Best Adjustment Strategy for Asthma in Long Term (BASALT) study, which is a separate Asthma Clinical Research Network (ACRN) study.
All TALC participants will then undergo three 16-week treatment periods, which will include the following:
The order in which the three treatment periods will occur will be randomly assigned for each participant. Each of the three 16-week treatment periods will consist of 14 weeks of treatment followed by a 2-week washout period, in which participants will receive a single does of ICS. Study visits will occur at baseline and Weeks 2 and 4 of the 4-week run-in period, and at Weeks 4, 9, 14, and 16 of each 16-week treatment period. Spirometry tests to measure lung function will occur at each study visit and exhaled nitric oxide testing and questionnaires to assess asthma control and symptoms will occur at most visits. During study visits at Week 4 of the run-in period and Week 14 of each treatment period, lung function measurements, sputum collection, questionnaires to assess asthma quality-of-life, and measurements of sleep and daytime alertness will all occur. Participants will also record asthma symptoms, peak flow measurements, and medication usage in a daily diary.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for TALC and BASALT Studies:
Asthma confirmed by one of the following two criteria:
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:
Inclusion Criteria for TALC Study:
Exclusion Criteria for BASALT and TALC Studies:
Exclusion Criteria for TALC Study:
Contacts and Locations| Contact: Vernon M. Chinchilli, PhD | 717-531-4262 | vchinchi@psu.edu |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Homer A. Boushey, MD 415-476-8019 homer.boushey@ucsf.edu | |
| Contact: Stephen Lazarus, MD 415-476-2091 lazma@ucsf.edu | |
| Principal Investigator: Homer A. Boushey, MD | |
| Sub-Investigator: Stephen Lazarus, MD | |
| University of California, San Diego | Recruiting |
| San Diego, California, United States, 92093 | |
| Contact: Stepehn I. Wasserman, MD 858-822-4261 swasserman@ucsd.edu | |
| Contact: Joe Ramsdell, MD 619-543-7241 jramsdell@ucsd.edu | |
| Principal Investigator: Stephen I. Wasserman, MD | |
| Sub-Investigator: Joe Ramsdell, MD | |
| United States, Colorado | |
| National Jewish Medical and Research Center | Recruiting |
| Denver, Colorado, United States, 80206 | |
| Contact: Richard J. Martin, MD 303-398-1545 martinr@njc.org | |
| Contact: Stanley J. Szefler, MD, PhD 303-270-2189 szeflers@njc.org | |
| Principal Investigator: Richard J. Martin, MD | |
| Sub-Investigator: Stanley J. Szefler, MD, PhD | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Elliot Israel, MD 617-732-8110 eisrael@partners.org | |
| Contact: Michael Wechsler, MD 617-732-7731 mwechsler@rics.bwh.harvard.edu | |
| Principal Investigator: Elliot Israel, MD | |
| Sub-Investigator: Michael Wechsler, MD | |
| United States, Missouri | |
| Washington University, St. Louis | Recruiting |
| St. Louis, Missouri, United States, 63130 | |
| Contact: Maruo Castro, MD 314-362-6904 castrom@im.wustl.edu | |
| Contact: Michael J. Walter, MD 314-362-8987 mwalter@im.wustl.edu | |
| Principal Investigator: Mario Castro, MD | |
| Sub-Investigator: Michael J. Walter, MD | |
| United States, New York | |
| Columbia University Health Sciences | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Emily A. DiMango, MD 212-305-0290 ead3@columbia.edu | |
| Principal Investigator: Emily A. DiMango, MD | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Stephen P. Peters, MD, PhD 336-713-7500 sppeters@wfubmc.edu | |
| Contact: Eugene Bleecker, MD 336-713-7500 ebleeck@wfubmc.edu | |
| Principal Investigator: Stephen P. Peters, MD, PhD | |
| Sub-Investigator: Eugene Bleecker, MD | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Monica Kraft, MD 919-479-0719 monica.kraft@duke.edu | |
| Principal Investigator: Monica Kraft, MD | |
| United States, Texas | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Contact: William J. Calhoun, MD 409-772-2436 wjcalhou@utmb.edu | |
| Contact: Bill T. Ameredes, PhD 409-772-8104 btamered@utmb.edu | |
| Principal Investigator: William J. Calhoun, MD | |
| Sub-Investigator: Bill T. Ameredes, PhD | |
| United States, Wisconsin | |
| University of Wisconsin, Madison | Recruiting |
| Madison, Wisconsin, United States, 53706 | |
| Contact: Robert F. Lemanske, MD 608-263-6184 rfl@medicine.wisc.edu | |
| Contact: Christine A. Sorkness, PharmD 608-262-8237 sorkness@facstaff.wisc.edu | |
| Principal Investigator: Robert F. Lemanske, MD | |
| Sub-Investigator: Christine A. Sorkness, PharmD | |
| Principal Investigator: | Homer A. Boushey, MD | University of California, San Francisco |
| Principal Investigator: | Richard J. Martin, MD | National Jewish Health |
| Principal Investigator: | Elliot Israel, MD | Brigham and Women's Hospital |
| Principal Investigator: | Stephen I. Wasserman, MD | University of California, San Diego |
| Principal Investigator: | Mario Castro, MD | Washington University, St. Louis |
| Study Chair: | Reuben M. Cherniack, MD | National Jewish Health |
| Principal Investigator: | Stephen P. Peters, MD, PhD | Wake Forest University |
| Principal Investigator: | Monica Kraft, MD | Duke University |
| Principal Investigator: | William J. Calhoun, MD | University of Texas |
| Principal Investigator: | Robert F. Lemanske, MD | University of Wisconsin, Madison |
| Principal Investigator: | Emily A. DiMango, MD | Columbia University Medical Center |
More Information
| Responsible Party: | Pennsylvania State University, College of Medicine ( Vernon M. Chinchilli, PhD ) |
| Study ID Numbers: | 547, U10 HL074073, U10 HL074204, U10 HL074206, U10 HL074208, U10 HL074212, U10 HL074218, U10 HL074225, U10 HL074227, U10 HL074231 |
| Study First Received: | November 28, 2007 |
| Last Updated: | February 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00565266 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Cholinergic Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Cholinergic Agents Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive |
Respiratory Tract Diseases Bromides Tiotropium Salmeterol Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Glucocorticoids Lung Diseases Hypersensitivity, Immediate Bronchodilator Agents Anticonvulsants Respiratory Hypersensitivity |
|
Anti-Inflammatory Agents Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Beclomethasone Cholinergic Agents Hormones Adrenergic Agonists Hypersensitivity |
Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Therapeutic Uses Tiotropium Salmeterol Immune System Diseases Adrenergic beta-Agonists Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate |
