Copd BronchitisPhase 2NCT00483743
Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients
A Phase 2 study testing TPI 1020 and Budesonide in people with Copd Bronchitis, run by Syntara at 13 sites in Canada.
Trial summary
This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Copd Bronchitis
- What is being tested?
- TPI 1020 and Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 13 sitesCanada
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
- Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD
Who cannot join
- COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
- Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
University of alberta Hsopital
Edmonton, Alberta, T6G2B7
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N4A6
Clinique Medical Les Saules
Les Saules, Quebec, G1P 1J6
Omnispec Clinical Research Inc.
Mirabel, Quebec, J7J 2K8
Hopital Thoracique Montreal-CSUM
Montreal, Quebec, H2X2P4
Hopital Sacre Coeur de Montreal
Montreal, Quebec, H4J1C5
Kells Medical Research Group
Pointe-Claire, Quebec, H9R 4S3
Complexe Medicale Langelier
Saint-Léonard, Quebec, H1S 3A9
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Diex Research Inc.
Sherbrooke, Quebec, J1H 1Z1
CHUS -Hopital FLEURIMONT
Sherbrooke, Quebec, J1H5N4
Centre de Cardiologie et de Pneumologie de l'Université Laval
Ste-Foy, Quebec, G1V 4G5
Vancouver Hospital Lung Center
Vancouver, British Columbia, V5Z 1 M9
About this study
Official title: Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.
This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.
Read the detailed description
A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.
- Conditions
- Copd Bronchitis
- Being tested
- TPI 1020, Budesonide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 1020Drug
250 mcg/caps 2 caps BID x 42 days
BudesonideDrug
400mcg mcg capsules- 2 capsules BID
PlaceboDrug
2 caps BID x42 days
| Study group | Role | What they receive |
|---|---|---|
| TPI 1020 | Experimental | TPI 1020 500 mcg BID x 42 days Receives: Drug: TPI 1020 |
| Budosenide cortico | Active comparator | Budesonide 800 mcg BID x 42 days Receives: Drug: Budesonide |
| Placebo | Placebo comparator | Placebo inhaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.
Measured: 42 days
Secondary outcomes (1)
Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Copd BronchitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Maltais, MD, Principal investigator, Centre de Cardiologie et de Pneumologie de l'Université LavalRene Pageau, M.Sc Pharm, Study director, Syntara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483743
- Sponsor's protocol ID
- TPI 1020-203
- Status last verified
- Nov 2012
- First submitted
- 23 May 2007
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Double-Blind, Placebo and Active-Controlled, 6-week Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI 1020 in COPD Patients.
- ClinicalTrials.gov ID
- NCT00483743
- Acronym / sponsor ID
- TPI 1020-203
- Conditions
- Copd Bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 Jun 2007 (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.
This study will assess and compare the safety and tolerability of inhaled TPI 1020 (repeated nominal doses; 500 μg BID x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg BID x 6 weeks) and a matching placebo. Pharmacodynamic (PD) activity on FEV1, sputum and blood cells and cytokines will also be studied.
Detailed description
A multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled TPI 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of TPI 1020 in 42 evaluable COPD subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPI 1020 | Experimental | Drug: TPI 1020TPI 1020 500 mcg BID x 42 days |
| Budosenide cortico | Active comparator | Drug: BudesonideBudesonide 800 mcg BID x 42 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhaler |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years.
- Age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate COPD
Key exclusion criteria (2 listed)
- COPD exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study.
- Failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for TCC and differential cell count determination.
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 |
|---|---|---|
| TPI 1020250 mcg/caps 2 caps BID x 42 days | Drug | TPI 1020 |
| Budesonide400mcg mcg capsules- 2 capsules BID | Drug | Budosenide cortico |
| Placebo2 caps BID x42 days | Drug | Placebo |
Primary outcome
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42.
Time frame: 42 days
1 secondary outcome
Sputum neutrophil counts on Days 0 and 21. • Trough FEV1, SVC and IC on Days 0, 21 and on Day 42. • eNO levels on Days 0, 21 and on Day 42.
Time frame: 42 days
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 3 Dec 2012.
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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.
Francois Maltais, MD principal investigator
Centre de Cardiologie et de Pneumologie de l'Université Laval
Rene Pageau, M.Sc Pharm study director
Syntara
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPI 1020 and Budesonide in people with Copd Bronchitis, run by Syntara at 13 sites in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the airway specific, and general safety and the tolerability of inhaled TPI 1020 administered via Aerolizer™ in COPD patients. • To assess the effects of TPI 1020 versus those of budesonide on sputum neutrophil counts on Days 0 and 42. (time frame: 42 days). 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 3 Dec 2012.