Pulmonary Disease, Chronic ObstructivePhase 4NCT00394485
Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients
A Phase 4 study testing Procaterol and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Otsuka Pharmaceutical, Inc., Philippines at 1 site in Philippines.
Trial summary
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Procaterol and Tiotropium
- How many people
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2006to Apr 2008
- Phase
- Phase 4
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOLD criteria for moderate COPD (post-bronchodilator)
- FEV1/FVC < 70%
- 50% ≤ FEV1 < 80% predicted
- With or without symptoms
- Willing to undergo the treatment protocol with signed informed consent
Who cannot join
- Exacerbation within 1 month prior to run-in period
- Significant hypoxemia and/or desaturation at rest and during exercise.
- Significant cardiac, renal, or other systemic disease
- History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital
Manila, National Capital Region, 1000
About this study
Official title: A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease
Read the detailed description
This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.
After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Procaterol, Tiotropium
- Keywords
- Chronic Obstructive Pulmonary Disease, Procaterol, Tiotropium
- 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.
ProcaterolDrug
TiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
Secondary outcomes (2)
[Safety] HR (Heart Rate) and BP (Blood Pressure)
Incidence of adverse reactions and changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study startMay 2006
- Study completionApr 2008
Why it stopped: Difficulty in recruting patients
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical, Inc., Philippines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Abundio A Balgos, MD, Principal investigator, University of the Philippines College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394485
- Sponsor's protocol ID
- OPPI-MPTA-COPD-1
- Status last verified
- Dec 2009
- First submitted
- 31 Oct 2006
- Last updated
- 17 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial Comparing the Efficacy and Safety of Tiotropium + Procaterol vs. Tiotropium + Placebo in Moderate COPD Patients
- ClinicalTrials.gov ID
- NCT00394485
- Acronym / sponsor ID
- OPPI-MPTA-COPD-1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, Procaterol, Tiotropium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruting patients
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical, Inc., PhilippinesIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- May 2006
- Study completion
- Apr 2008
- First posted
- 1 Nov 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.
Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease
Detailed description
This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.
After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- GOLD criteria for moderate COPD (post-bronchodilator)
- Willing to undergo the treatment protocol with signed informed consent
Key exclusion criteria (4 listed)
- Exacerbation within 1 month prior to run-in period
- Significant hypoxemia and/or desaturation at rest and during exercise.
- Significant cardiac, renal, or other systemic disease
- History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
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 |
|---|---|---|
| Procaterol | Drug | – |
| Tiotropium | Drug | – |
Primary outcome
[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks
2 secondary outcomes
[Safety] HR (Heart Rate) and BP (Blood Pressure)
Incidence of adverse reactions and changes
Results and safety
The study was stopped early (reason given: Difficulty in recruting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2009.
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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.
Abundio A Balgos, MD principal investigator
University of the Philippines College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Procaterol and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Otsuka Pharmaceutical, Inc., Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Difficulty in recruting patients). Results are not available in the source record.
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?
[Efficacy] Improvement spirometry (FEV1, FVC, FEV1/FVC, 6 MWD, TDI) and SGRQ at 2 weeks. 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 17 Dec 2009.