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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)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00565266
First received: November 28, 2007
Last updated: April 5, 2013
Last verified: April 2013
Results First Received: April 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: tiotropium bromide
Drug: salmeterol xinafoate
Drug: beclomethasone dipropionate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants

All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:

  • tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
  • salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
  • beclomethasone dipropionate 160 mcg twice daily (2xICS)

Participant Flow:   Overall Study
    All Participants  
STARTED     210  
COMPLETED     174  
NOT COMPLETED     36  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Participants All participants randomized into the six-sequence crossover study

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  210  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     207  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  42.2  ± 12.3  
Gender  
[units: participants]
 
Female     141  
Male     69  
Region of Enrollment  
[units: participants]
 
United States     210  



  Outcome Measures

1.  Primary:   Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)   [ Time Frame: AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0. ]

2.  Secondary:   Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Asthma Symptoms, Number of Asthma-control Days, Rescue Inhaler Use   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Asthma Control, Asthma Quality-of-life   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Asthma Exacerbations   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Biomarkers of Inflammation and Oxidative Stress   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Adverse Events   [ Time Frame: Measured during each of the three 14-week treatment periods ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vernon M. Chinchilli, PhD
Organization: Penn State Hershey College of Medicine
phone: 717-531-4262
e-mail: vchinchi@psu.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00565266     History of Changes
Other Study ID Numbers: 547, U10 HL074206, U10 HL074208, U10 HL074073, U10 HL074227, U10 HL074225, U10 HL074204, U10 HL074218, U10 HL074212, U10HL074231
Study First Received: November 28, 2007
Results First Received: April 30, 2012
Last Updated: April 5, 2013
Health Authority: United States: Federal Government