Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239421
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2005-10-14
Brief Title:
A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Six-Week Randomized Double-Blind Quadruple-Dummy Parallel Group Multiple Dose Study Comparing the Efficacy and Safety of Tiotropium Inhalation Capsules Plus Formoterol Inhalation Capsules to Salmeterol Inhalation Aerosol Plus Fluticasone Inhalation Aerosol in Patients With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients
Detailed Description:
Tiotropium Spiriva is a once-daily inhaled anticholinergic for the treatment of COPD A six-week multicentre randomized double-blind parallel group study was conducted to compare the efficacy and safety of the free combination of tiotropium 18 µg once daily plus formoterol 12 µg bid TioFor to salmeterol 50 µg bid plus fluticasone 500 µg bid SalFlu in COPD patients Information regarding the differential efficacy and safety of the two different combinations may be essential for physicians to make informed choices of therapy for COPD patients considered candidates for combination therapy
Following an initial screening visit subjects entered a two or four-week run-in period in which they received ipratropium Atrovent on a regular basis At the second visit Baseline subjects were randomized into the six-week double blind portion of the study in which they received either TioFor or SalFlu After three weeks of treatment an interim visit was scheduled After six weeks of treatment a 12-hour profile of pulmonary function testings FEV1 FVC was obtained Spirometric measurements were performed at pre-dose and 30 minutes 1 2 3 4 6 8 10 and 12 hours post-dosing There were two co-primary endpoints FEV1 area under the curve for the time period 0 to 12 hours FEV1 AUC0-12 and peak FEV1
The efficacy evaluation intention-to-treat comprised 592 patients TioFor N297 SalFlu N295 The two treatment groups were comparable with regard to demographic data and baseline disease characteristics Baseline FEV1 SE TioFor 1310 L 0026 L SalFlu 1325 L 0025 L Adjustment was done for baseline and centre-effects
Study Hypothesis
The following primary hypotheses one-sided were tested with regard to superiority all means are adjusted means
H01 FEV1AUC0-12 hours tiotropiumformoterol FEV1AUC 0-12 hours salmeterolfluticasone versus H11 FEV1AUC0-12 hours tiotropiumformoterol FEV1AUC 0-12 hourssalmeterolfluticasone
It was stipulated in the protocol that if the null hypothesis H01 was rejected in favour of H11 then the following hypothesis would be tested
H01 Peak FEV1 tiotropiumformoterol Peak FEV1 salmeterolfluticasone versus H11 Peak FEV1 tiotropiumformoterol Peak FEV1 salmeterolfluticasone
Each step was only considered confirmatory providing all previous steps were successful If any of the previous steps were not successful any analysis of the current step would have been considered descriptive
Comparisons
Test therapy
Test product Tiotropium inhalation capsules plus formoterol inhalation capsules Dose 18 µg tiotropium per day one capsule 12 µg formoterol twice daily two times one capsule Mode of administration inhalation via the Handihaler device tiotropium inhalation via the Blue Inhaler device formoterol
Reference therapy
Test product Salmeterol plus fluticasone propionate Dose Salmeterol 50 µg 2 puffs of 25 µg each bid fluticasone propionate 500 µg 2 puffs of 250 µg each bid
Mode of administration inhalation via MDI
The treatment duration was 42 days each Primary endpoint measurements were performed on the last treatment day
Following an initial screening visit subjects entered a two or four-week run-in period in which they received ipratropium Atrovent on a regular basis At the second visit Baseline subjects were randomized into the six-week double blind portion of the study in which they received either TioFor or SalFlu After three weeks of treatment an interim visit was scheduled After six weeks of treatment a 12-hour profile of pulmonary function testings FEV1 FVC was obtained Spirometric measurements were performed at pre-dose and 30 minutes 1 2 3 4 6 8 10 and 12 hours post-dosing There were two co-primary endpoints FEV1 area under the curve for the time period 0 to 12 hours FEV1 AUC0-12 and peak FEV1
The efficacy evaluation intention-to-treat comprised 592 patients TioFor N297 SalFlu N295 The two treatment groups were comparable with regard to demographic data and baseline disease characteristics Baseline FEV1 SE TioFor 1310 L 0026 L SalFlu 1325 L 0025 L Adjustment was done for baseline and centre-effects
Study Hypothesis
The following primary hypotheses one-sided were tested with regard to superiority all means are adjusted means
H01 FEV1AUC0-12 hours tiotropiumformoterol FEV1AUC 0-12 hours salmeterolfluticasone versus H11 FEV1AUC0-12 hours tiotropiumformoterol FEV1AUC 0-12 hourssalmeterolfluticasone
It was stipulated in the protocol that if the null hypothesis H01 was rejected in favour of H11 then the following hypothesis would be tested
H01 Peak FEV1 tiotropiumformoterol Peak FEV1 salmeterolfluticasone versus H11 Peak FEV1 tiotropiumformoterol Peak FEV1 salmeterolfluticasone
Each step was only considered confirmatory providing all previous steps were successful If any of the previous steps were not successful any analysis of the current step would have been considered descriptive
Comparisons
Test therapy
Test product Tiotropium inhalation capsules plus formoterol inhalation capsules Dose 18 µg tiotropium per day one capsule 12 µg formoterol twice daily two times one capsule Mode of administration inhalation via the Handihaler device tiotropium inhalation via the Blue Inhaler device formoterol
Reference therapy
Test product Salmeterol plus fluticasone propionate Dose Salmeterol 50 µg 2 puffs of 25 µg each bid fluticasone propionate 500 µg 2 puffs of 250 µg each bid
Mode of administration inhalation via MDI
The treatment duration was 42 days each Primary endpoint measurements were performed on the last treatment day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None