Trial Outcomes & Findings for 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) (NCT NCT00565266)
NCT ID: NCT00565266
Last Updated: 2018-07-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
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.
Results posted on
2018-07-02
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
210
|
|
Overall Study
COMPLETED
|
174
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
All Participants
n=210 Participants
All participants randomized into the six-sequence crossover study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
207 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
210 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)
|
24.4 Liters per minute
Standard Error 4.2
|
18.0 Liters per minute
Standard Error 3.2
|
-1.4 Liters per minute
Standard Error 3.5
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Forced Expiratory Volume in One Second (FEV1)
|
0.12 liters
Standard Error 0.025
|
0.01 liters
Standard Error 0.025
|
0.02 liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
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 )
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in Asthma Symptoms
|
-0.09 units on a scale
Standard Error 0.018
|
-0.04 units on a scale
Standard Error 0.018
|
0.03 units on a scale
Standard Error 0.018
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
Scores on the Asthma Quality-of-Life Questionnaire range from 1 to 7, with a higher score indicating a better quality of life.
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Asthma Quality-of-life Questionnaire Score
|
0.15 units on a scale
Standard Error 0.058
|
0.28 units on a scale
Standard Error 0.050
|
0.05 units on a scale
Standard Error 0.052
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
Scores on the Asthma Control Questionnaire range from 0 to 6, with a higher score indicating worse asthma control.
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Asthma Control Questionnaire Score
|
-0.22 units on a scale
Standard Error 0.055
|
-0.31 units on a scale
Standard Error 0.045
|
-0.03 units on a scale
Standard Error 0.048
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
Total number of puffs from the albuterol (rescue) inhaler during the previous 24 hours (excluding those puffs for preventive use).
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Albuterol Rescue Puffs Per Day
|
-0.11 puffs per day
Standard Error 0.058
|
-0.16 puffs per day
Standard Error 0.063
|
-0.07 puffs per day
Standard Error 0.063
|
SECONDARY outcome
Timeframe: 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.Population: All randomized participants were included in the linear mixed-effects model analysis
An asthma control day was defined as a day in which there were no symptoms and no albuterol (rescue) puffs.
Outcome measures
| Measure |
Tio + 1xICS
n=210 Participants
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=210 Participants
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=210 Participants
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Change Between Week 14 and Week 0 in the Proportion of Asthma Control Days
|
0.13 proportion of asthma control days
Standard Error 0.020
|
0.14 proportion of asthma control days
Standard Error 0.023
|
0.05 proportion of asthma control days
Standard Error 0.021
|
Adverse Events
Tio + 1xICS
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
LABA + 1xICS
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
2xICS
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tio + 1xICS
n=203 participants at risk
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=196 participants at risk
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=195 participants at risk
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
hospitalization due to pneumonia
|
0.99%
2/203 • Number of events 2 • 1 year
does not differ from clinicaltrials.gov definitions
|
0.00%
0/196 • 1 year
does not differ from clinicaltrials.gov definitions
|
0.51%
1/195 • Number of events 1 • 1 year
does not differ from clinicaltrials.gov definitions
|
|
General disorders
unrelated events
|
0.49%
1/203 • Number of events 1 • 1 year
does not differ from clinicaltrials.gov definitions
|
2.0%
4/196 • Number of events 4 • 1 year
does not differ from clinicaltrials.gov definitions
|
1.5%
3/195 • Number of events 3 • 1 year
does not differ from clinicaltrials.gov definitions
|
Other adverse events
| Measure |
Tio + 1xICS
n=203 participants at risk
tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
LABA + 1xICS
n=196 participants at risk
salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
|
2xICS
n=195 participants at risk
beclomethasone dipropionate 160 mcg twice daily (2xICS)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
urgent care visit due to asthma
|
0.99%
2/203 • Number of events 2 • 1 year
does not differ from clinicaltrials.gov definitions
|
1.0%
2/196 • Number of events 2 • 1 year
does not differ from clinicaltrials.gov definitions
|
3.1%
6/195 • Number of events 6 • 1 year
does not differ from clinicaltrials.gov definitions
|
Additional Information
Vernon M. Chinchilli, PhD
Penn State Hershey College of Medicine
Phone: 717-531-4262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place