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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) (TALC)

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ClinicalTrials.gov Identifier: NCT00565266
Recruitment Status : Completed
First Posted : November 29, 2007
Results First Posted : April 9, 2013
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: tiotropium bromide
Drug: salmeterol xinafoate
Drug: beclomethasone dipropionate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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.
No text entered.

Reporting Groups
  Description
All Participants All participants randomized into the six-sequence crossover study

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 210 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      207  98.6% 
>=65 years      3   1.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.2  (12.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      141  67.1% 
Male      69  32.9% 
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.  

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.  

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.  

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.  

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.  

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.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
We evaluated only a small number of patients, with no treatment lasting longer than 14 weeks. We could not examine either the rate of asthma exacerbations or long-term safety issues, so our findings cannot be considered clinically directive.


  More Information

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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vernon M. Chinchilli, PhD, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00565266     History of Changes
Other Study ID Numbers: 547
U10HL074206 ( U.S. NIH Grant/Contract )
U10HL074208 ( U.S. NIH Grant/Contract )
U10HL074073 ( U.S. NIH Grant/Contract )
U10HL074227 ( U.S. NIH Grant/Contract )
U10HL074225 ( U.S. NIH Grant/Contract )
U10HL074204 ( U.S. NIH Grant/Contract )
U10HL074218 ( U.S. NIH Grant/Contract )
U10HL074212 ( U.S. NIH Grant/Contract )
U10HL074231 ( U.S. NIH Grant/Contract )
First Submitted: November 28, 2007
First Posted: November 29, 2007
Results First Submitted: April 30, 2012
Results First Posted: April 9, 2013
Last Update Posted: December 28, 2017