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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 : July 2, 2018
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
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Participants
Hide Arm/Group Description

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)
Period Title: Overall Study
Started 210
Completed 174
Not Completed 36
Arm/Group Title All Participants
Hide Arm/Group Description All participants randomized into the six-sequence crossover study
Overall Number of Baseline Participants 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
<=18 years
0
   0.0%
Between 18 and 65 years
207
  98.6%
>=65 years
3
   1.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 210 participants
42.2  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 210 participants
Female
141
  67.1%
Male
69
  32.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 210 participants
210
1.Primary Outcome
Title Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)
Hide Description [Not Specified]
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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: Liters per minute
24.4  (4.2) 18.0  (3.2) -1.4  (3.5)
2.Secondary Outcome
Title Change Between Week 14 and Week 0 in the Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame FEV1 was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: liters
0.12  (0.025) 0.01  (0.025) 0.02  (0.025)
3.Secondary Outcome
Title Change Between Week 14 and Week 0 in Asthma Symptoms
Hide Description

Asthma symptoms were recorded as 0 (absent = no symptom )

  1. (mild = symptom was minimally troublesome, i.e. not sufficient to interfere with normal daily activity or sleep)
  2. (moderate = symptom was sufficiently troublesome to interfere with normal daily activity or sleep)
  3. (severe = symptom was so severe as to prevent normal activity and/or sleep )
Time Frame Asthma symptoms were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.09  (0.018) -0.04  (0.018) 0.03  (0.018)
4.Secondary Outcome
Title Change Between Week 14 and Week 0 in the Asthma Quality-of-life Questionnaire Score
Hide Description Scores on the Asthma Quality-of-Life Questionnaire range from 1 to 7, with a higher score indicating a better quality of life.
Time Frame The asthma quality-of-life questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.15  (0.058) 0.28  (0.050) 0.05  (0.052)
5.Secondary Outcome
Title Change Between Week 14 and Week 0 in the Asthma Control Questionnaire Score
Hide Description Scores on the Asthma Control Questionnaire range from 0 to 6, with a higher score indicating worse asthma control.
Time Frame The asthma control questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.22  (0.055) -0.31  (0.045) -0.03  (0.048)
6.Secondary Outcome
Title Change Between Week 14 and Week 0 in the Albuterol Rescue Puffs Per Day
Hide Description Total number of puffs from the albuterol (rescue) inhaler during the previous 24 hours (excluding those puffs for preventive use).
Time Frame Albuterol rescue puffs were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: puffs per day
-0.11  (0.058) -0.16  (0.063) -0.07  (0.063)
7.Secondary Outcome
Title Change Between Week 14 and Week 0 in the Proportion of Asthma Control Days
Hide Description An asthma control day was defined as a day in which there were no symptoms and no albuterol (rescue) puffs.
Time Frame An asthma control day was determined daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants were included in the linear mixed-effects model analysis
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 210 210 210
Least Squares Mean (Standard Error)
Unit of Measure: proportion of asthma control days
0.13  (0.020) 0.14  (0.023) 0.05  (0.021)
Time Frame 1 year
Adverse Event Reporting Description does not differ from clinicaltrials.gov definitions
 
Arm/Group Title Tio + 1xICS LABA + 1xICS 2xICS
Hide Arm/Group Description 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)
All-Cause Mortality
Tio + 1xICS LABA + 1xICS 2xICS
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tio + 1xICS LABA + 1xICS 2xICS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/203 (1.48%)      4/196 (2.04%)      4/195 (2.05%)    
General disorders       
unrelated events   1/203 (0.49%)  1 4/196 (2.04%)  4 3/195 (1.54%)  3
Respiratory, thoracic and mediastinal disorders       
hospitalization due to pneumonia   2/203 (0.99%)  2 0/196 (0.00%)  0 1/195 (0.51%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Tio + 1xICS LABA + 1xICS 2xICS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/203 (0.99%)      2/196 (1.02%)      6/195 (3.08%)    
Respiratory, thoracic and mediastinal disorders       
urgent care visit due to asthma   2/203 (0.99%)  2 2/196 (1.02%)  2 6/195 (3.08%)  6
Indicates events were collected by systematic assessment
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.
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
Layout table for Results Point of Contact information
Name/Title: Vernon M. Chinchilli, PhD
Organization: Penn State Hershey College of Medicine
Phone: 717-531-4262
EMail: vchinchi@psu.edu
Layout table for additonal information
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: July 2, 2018