Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274079
Status:
COMPLETED
Last Update Posted:
2013-11-01
First Post:
2006-01-09
Brief Title:
SPIRIVA in Ususal Care
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blind Parallel Group 12 Week Study Comparing the Effect of Once Daily Tiotropium Lactose Capsule With Placebo in Patients With Chronic Obstructive Pulmonary Disease COPD naïve to Anticholinergic Agents in Addition to Receiving Their Usual COPD Care
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:
The objective of the study is to determine the effect on lung function when either SPIRIVA once daily or placebo once daily is added to the usual therapy care of COPD patients naïve to anticholinergic agents managed in primary care Previous studies have been in both hospital in and outpatients with washout of some respiratory medications this is the first study to be conducted in General Practice the drugs anticipated environment
Data from this study including the adverse event monitoring and post study findings on physical examination will be used to extend the safety database Health Resource Utilisation HRU data will be recorded to be use with data from other sources for economic analysis of COPD treatment
Data from this study including the adverse event monitoring and post study findings on physical examination will be used to extend the safety database Health Resource Utilisation HRU data will be recorded to be use with data from other sources for economic analysis of COPD treatment
Detailed Description:
Anticholinergic drugs are currently indicated for all severities of COPD due to the dominance of cholinergic tone in the pathological process of the disease SPIRIVA is a new long acting anticholinergic which has showed the benefits of improved lung function dyspnoea health status and less exacerbations compared to ipratropium salmeterol and placebo in secondary care hospital setting The study will determine if the same effect is seen on the on lung function and dyspnoea when either SPIRIVA or placebo is added to the usual therapy care of COPD patients naïve to anticholinergic agents managed in primary care
The one year placebo and active controlled studies have confirmed efficacy and safety No evidence of tolerance to the bronchodilator effects of tiotropium has been seen Consistent improvements of health outcomes were also demonstrated In the one-year studies statistically significantly fewer patients in the tiotropium groups experienced exacerbations or were hospitalised for exacerbations Additionally time to first exacerbation was increased This suggests that moderate and severe exacerbations are reduced in-patients treated with tiotropium The mechanism underlying this is not known but may be associated with sustained airway opening
The study will involve five visits to the GP surgery over a period of 14 weeks Patient will attend for an initial visit to have the study information given to them and obtain their written consent At the subsequent screening visit a physical examination including ECG together with an assessment of lung function will be performed Once eligibility to the study is confirmed and after completion of a 14 day run-in period patients will start treatment with a daily inhalation from the HandiHaler device of either SPIRIVA or placebo this in addition to their usual COPD therapy
Throughout the 12 week treatment period patients will be required to inhale their study treatment medication each morning and complete a diary card Patients will be required to return to the surgery after 2 and 6 weeks with the final visit at 12 weeks for lung function testing assessment of symptoms using the Oxygen Cost Diagram OCD Health Resources Utilisation HRU and any adverse events On completion of the 12 week treatment period a full physical examination will be repeated Adverse event monitoring including COPD exacerbations will take place throughout the study
Study Hypothesis
Based on previous studies on COPD patients who were not on long acting beta agonists LABAs the standard deviation SD for trough FEV1 was 215 ml and an effect of 130 ml was seen on mean trough FEV1 with tiotropium
It is assumed that 20 of primary care managed COPD patients will be using LABAs as part of their usual care The effect of tiotropium on mean trough FEV1 in the study population is expected to be lower than the 130 ml seen in previous studies Placebo is not expected to have any effect on mean trough FEV1
Assuming an SD of 235ml a total of 348 patients 174 per group is adequate to detect a difference of 100 ml in mean trough FEV1 response between treatments with at the least 95 power at the 25 level of significance one-sided using a two group t-test
To be considered complete a patient must complete all primary efficacy data for all study visits as specified in the protocol without violations of the protocol so significant as to obscure the response to treatment
Comparisons
Usual care for COPD
The one year placebo and active controlled studies have confirmed efficacy and safety No evidence of tolerance to the bronchodilator effects of tiotropium has been seen Consistent improvements of health outcomes were also demonstrated In the one-year studies statistically significantly fewer patients in the tiotropium groups experienced exacerbations or were hospitalised for exacerbations Additionally time to first exacerbation was increased This suggests that moderate and severe exacerbations are reduced in-patients treated with tiotropium The mechanism underlying this is not known but may be associated with sustained airway opening
The study will involve five visits to the GP surgery over a period of 14 weeks Patient will attend for an initial visit to have the study information given to them and obtain their written consent At the subsequent screening visit a physical examination including ECG together with an assessment of lung function will be performed Once eligibility to the study is confirmed and after completion of a 14 day run-in period patients will start treatment with a daily inhalation from the HandiHaler device of either SPIRIVA or placebo this in addition to their usual COPD therapy
Throughout the 12 week treatment period patients will be required to inhale their study treatment medication each morning and complete a diary card Patients will be required to return to the surgery after 2 and 6 weeks with the final visit at 12 weeks for lung function testing assessment of symptoms using the Oxygen Cost Diagram OCD Health Resources Utilisation HRU and any adverse events On completion of the 12 week treatment period a full physical examination will be repeated Adverse event monitoring including COPD exacerbations will take place throughout the study
Study Hypothesis
Based on previous studies on COPD patients who were not on long acting beta agonists LABAs the standard deviation SD for trough FEV1 was 215 ml and an effect of 130 ml was seen on mean trough FEV1 with tiotropium
It is assumed that 20 of primary care managed COPD patients will be using LABAs as part of their usual care The effect of tiotropium on mean trough FEV1 in the study population is expected to be lower than the 130 ml seen in previous studies Placebo is not expected to have any effect on mean trough FEV1
Assuming an SD of 235ml a total of 348 patients 174 per group is adequate to detect a difference of 100 ml in mean trough FEV1 response between treatments with at the least 95 power at the 25 level of significance one-sided using a two group t-test
To be considered complete a patient must complete all primary efficacy data for all study visits as specified in the protocol without violations of the protocol so significant as to obscure the response to treatment
Comparisons
Usual care for COPD
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