Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144196
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2005-09-02
Brief Title:
12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines SPIRIMILD
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A 12-week Double-blind Randomised Parallel-group Multi-centre Study Evaluating the Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines SPIRIMILD
Status:
COMPLETED
Status Verified Date:
2023-11
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 show that treatment with tiotropium inhalation capsules 18 μg qd via HandiHaler improves lung function in patients with mild COPD according to Swedish guidelines
Detailed Description:
Following an initial screening at the screening visitVisit 1 patients enter a 2 week run-in period Patients are allowed to take salbutamol Ventoline Diskus 02 mg prn as rescue medication and have to record their daily use of it on the Patients Diary Patients who meet all inclusion and none of the exclusion criteria at the check at Visit 2 will be randomised thereafter into the randomised treatment period of the study during which they will receive either tiotropiumSpiriva or placebo in blinded fashion
On Day 0 Visit 2 the first administration of blinded study medication tiotropiumSpiriva or matching placebo will be performed at the study site after a pre-dose pulmonary function test PFT has been carried out First administration of blinded study medication will be monitored by the investigator Post dose PFTs will be performed at 30 min 1 and 2 hours
On Days 1 to 83 except Day 14 the blinded study medication will be self-administered by the patients at home The patients will inhale one capsule tiotropiumSpiriva or matching placebo using the HandiHaler device once daily in the morning The morning dose of the blinded study medication should be taken at approximately the same time each morning between 700 am and 1000 am
At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes 1 and 2 hours
Study Hypothesis
The rationale of the study is to show that treatment with tiotropium Spiriva 18 g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines ie a post-bronchodilator FEV1 60 of predicted normal and FEV1 70 of FVC
Comparisons
One group will be treated with inhalation powder capsules of tiotropium Spiriva 18 micrograms once daily The other group will be treated with matching placebo Randomisation is 11
On Day 0 Visit 2 the first administration of blinded study medication tiotropiumSpiriva or matching placebo will be performed at the study site after a pre-dose pulmonary function test PFT has been carried out First administration of blinded study medication will be monitored by the investigator Post dose PFTs will be performed at 30 min 1 and 2 hours
On Days 1 to 83 except Day 14 the blinded study medication will be self-administered by the patients at home The patients will inhale one capsule tiotropiumSpiriva or matching placebo using the HandiHaler device once daily in the morning The morning dose of the blinded study medication should be taken at approximately the same time each morning between 700 am and 1000 am
At visit 3 and 4 PFTs will be performed predose and post dose at 30 minutes 1 and 2 hours
Study Hypothesis
The rationale of the study is to show that treatment with tiotropium Spiriva 18 g inhalation capsule via HandiHaler once daily improves FEV1 when compared with placebo in patients with mild COPD according to Swedish guidelines ie a post-bronchodilator FEV1 60 of predicted normal and FEV1 70 of FVC
Comparisons
One group will be treated with inhalation powder capsules of tiotropium Spiriva 18 micrograms once daily The other group will be treated with matching placebo Randomisation is 11
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