AsthmaPhase 2NCT00327808
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
A Phase 2 study testing TPI-1020 and budesonide in people with Asthma, run by Syntara at 7 sites in Canada.
Trial summary
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- TPI-1020 and budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 7 sitesCanada
- Study dates
- May 2006to Mar 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 through 65 years of age.
- Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
- Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1
- History of episodic wheeze and shortness of breath
- Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
Who cannot join
- History or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator
- History of serious adverse reaction or hypersensitivity to corticosteroids
- Abnormal chest X-ray that is judged clinically significant
- Pregnant or lactating or have positive plasma pregnancy test
- Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
- Use of any other asthma-related medications within 1 month of Screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
McMaster University Hospital
Hamilton, Ontario, L8N 3Z5
Kingston General Hospital
Kingston, Ontario, K7L 106
CARL
Laval, Quebec, H7V 3Y7
Montreal Chest Institute
Montreal, Quebec, H2X 2P4
Hopital Sacre Coeur
Montreal, Quebec, H4J 1G5
Centre Hospitalier St-Sacrement
Ste-Foy, Quebec, G1S 4L8
Institut Universitaire de Cardiologie et de Pneumologie de l'Hopital Laval
Ste-Foy, Quebec, G1V 4G5
About this study
Official title: Multi-Center, Randomized, Double-Blind, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
Read the detailed description
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
- Conditions
- Asthma
- Being tested
- TPI-1020, budesonide
- Keywords
- Smokers, Adults, Inflammatory markers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI-1020Drug
600 mcg BID x 14 days followed by 1200 mcg BID x 7 days
budesonideDrug
400 mcg BID x 14 days then 800 mcg/day x 7 more days
| Study group | Role | What they receive |
|---|---|---|
| Inhaler | Experimental | TPI 1020 Receives: Drug: TPI-1020 |
| Inhaler cortico. | Active comparator | Budesonide inhaler Receives: Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Measured: 22 days
Secondary outcomes (6)
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
Measured: 22 days
To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14
Measured: 22 days
To compare pre-dose FEV1 measurements on multiple days throughout the study
Measured: 22 days
To compare peak flow measurements throughout the study
Measured: 22 days
To compare the use of daily rescue medication (salbutamol) throughout the study
Measured: 22 days
To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntara
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paolo Renzi, MD, Study director, Syntara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327808
- Sponsor's protocol ID
- TPI 1020-202
- Status last verified
- Nov 2012
- First submitted
- 17 May 2006
- 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, Repeated Doses Study to Evaluate the Safety, Tolerability and Pharmacodynamic Activity of Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
- ClinicalTrials.gov ID
- NCT00327808
- Acronym / sponsor ID
- TPI 1020-202
- Conditions
- Asthma
- Keywords
- Smokers, Adults, Inflammatory markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- SyntaraIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 19 May 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.
The investigators will look at TPI-1020 safety and tolerability in mild to moderate asthmatic smoker subjects.
Detailed description
This study will assess and compare the safety and tolerability of inhaled TPI 1020 versus budesonide. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will also be studied in a sub-group of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaler | Experimental | Drug: TPI-1020TPI 1020 |
| Inhaler cortico. | Active comparator | Drug: budesonideBudesonide inhaler |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females 18 through 65 years of age.
- Smoking history of more than 5 pack/years but less than 25 pack/years and who have no desire to quit smoking despite physician's advice and who currently smoke at least 5 cigarettes per day.
- Mild to moderate, stable, allergic asthma as defined by American Thoracic Society (ATS) criteria 1
- History of episodic wheeze and shortness of breath
- Subjects currently and only receiving inhaled short-acting bronchodilator treatment for asthma.
Key exclusion criteria (6 listed)
- History or symptoms of significant autoimmune, hematological, or neurological disease, including transient ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances that are judged clinically significant by the Investigator
- History of serious adverse reaction or hypersensitivity to corticosteroids
- Abnormal chest X-ray that is judged clinically significant
- Pregnant or lactating or have positive plasma pregnancy test
- Use of oral/parenteral/inhaled corticosteroids within the last 28 days or injectable depot corticosteroids within the last 6 weeks.
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-1020600 mcg BID x 14 days followed by 1200 mcg BID x 7 days | Drug | Inhaler |
| budesonide400 mcg BID x 14 days then 800 mcg/day x 7 more days | Drug | Inhaler cortico. |
Primary outcome
To determine the safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke
Time frame: 22 days
6 secondary outcomes
To compare sputum neutrophil and eosinophil counts on Day 0 versus Day 15 and Day 22
Time frame: 22 days
To determine pharmacodynamic effects on forced expiratory volume in 1 second (FEV1) over 8 hours on Day 1 and Day 14
Time frame: 22 days
To compare pre-dose FEV1 measurements on multiple days throughout the study
Time frame: 22 days
To compare peak flow measurements throughout the study
Time frame: 22 days
To compare the use of daily rescue medication (salbutamol) throughout the study
Time frame: 22 days
To determine the plasma pharmacokinetic (PK) profile on a sub-group of subjects on the first and last day of the dosing period
Time frame: 22 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Paolo Renzi, MD study director
Syntara
7 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 Asthma, run by Syntara at 7 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 5 inclusion and 6 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 7 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. 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 safety and tolerability of multiple doses of TPI-1020 in subjects with asthma who smoke (time frame: 22 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.