Pulmonary Disease, Chronic ObstructivePhase 3NCT00274534
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.
A Phase 3 study testing Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 sites in United States.
Trial summary
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium and Salmeterol
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2000to Jul 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hines Veterans Administration Hospital
Hines, Illinois
Hunter Holmes McGuire Medical Center
Richmond, Virginia
About this study
Official title: A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Salmeterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
SalmeterolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.
Measured: up to day 90
Secondary outcomes (8)
Maximum decline in PaO2 from baseline
Measured: up to day 90
Maximum increase in alveolar-arterial oxygen gradient from baseline
Measured: up to day 90
Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter
Measured: up to day 90
Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter
Measured: up to day 90
Rescue medication use
Measured: up to day 90
COPD symptom score
Measured: up to day 90
Occurrence of adverse events
Measured: up to day 90
Pulse rate and sitting blood pressure in conjunction with spirometry
Measured: up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startDec 2000
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274534
- Sponsor's protocol ID
- 205.234
- Status last verified
- Nov 2013
- First submitted
- 9 Jan 2006
- Last updated
- 5 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00274534
- Acronym / sponsor ID
- 205.234
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Study completion
- Jul 2003
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium | Drug | – |
| Salmeterol | Drug | – |
Primary outcome
The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period.
Time frame: up to day 90
8 secondary outcomes
Maximum decline in PaO2 from baseline
Time frame: up to day 90
Maximum increase in alveolar-arterial oxygen gradient from baseline
Time frame: up to day 90
Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter
Time frame: up to day 90
Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter
Time frame: up to day 90
Rescue medication use
Time frame: up to day 90
COPD symptom score
Time frame: up to day 90
Occurrence of adverse events
Time frame: up to day 90
Pulse rate and sitting blood pressure in conjunction with spirometry
Time frame: up to day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period. (time frame: up to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2013.