AsthmaPhase 1NCT00989521
Effect of PUR003 on Asthma
A Phase 1 study testing PUR003 in people with Asthma and Lung Diseases, run by Pulmatrix Inc. at 1 site in Canada.
Trial summary
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma. Study objectives are to : 1. to evaluate the safety of PUR003 in subjects with asthma, and 2. to evaluate the efficacy of PUR003 in assisting the treatment of asthma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Lung Diseases, Bronchial Diseases
- What is being tested?
- PUR003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Oct 2011
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed written informed consent.
- Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
- Adult male or female subject, 18-60 years of age.
- Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
- No smoking within six months prior to entry
- Must be medically stable.
- Female subjects must have a negative pregnancy test
- Subjects of child bearing potential should be sexually inactive (abstinent) for 14 days prior to the first dose of study medication or using an acceptable form of birth control methods.
Who cannot join
- History or presence of significant co-existing chronic diseases.
- History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
- Pregnancy, breastfeeding.
- Abused alcohol or illicit drugs that required treatment.
- Participated in any other investigational drug evaluation within last 30 days.
- Scheduled to have elective or invasive medical intervention, procedure, or surgery within 6 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6
About this study
Official title: Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.
Study objectives are to :
- to evaluate the safety of PUR003 in subjects with asthma, and
- to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
- Conditions
- Asthma, Lung Diseases, Bronchial Diseases
- Being tested
- PUR003, Placebo
- Keywords
- Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases
- Medical subject headings
- Asthma, Lung Diseases, Bronchial Diseases, Bronchitis, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR003Drug
PUR003 for inhalation
PlaceboDrug
Normal saline for inhalation
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | normal saline for inhalation Receives: Drug: Placebo |
| PUR003 | Active comparator | PUR003 for inhalation Receives: Drug: PUR003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
Measured: after three doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionOct 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmatrix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health, McMaster University
- Investigators
- Parameswaran Nair, MD, PhD, Principal investigator, St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989521
- Sponsor's protocol ID
- 601-1V2
- Status last verified
- Nov 2011
- First submitted
- 2 Oct 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled Crossover Evaluation of the Effect of PUR003 on Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00989521
- Acronym / sponsor ID
- 601-1V2
- Conditions
- Asthma, Lung Diseases, Bronchial Diseases
- Keywords
- Asthma, bronchial diseases, lung diseases, bronchitis, respiratory tract diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pulmatrix Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health, McMaster University
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Oct 2009 (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.
PUR003 is an inhaled substance that is proposed to assist in the treatment of asthma.
Study objectives are to :
- to evaluate the safety of PUR003 in subjects with asthma, and
- to evaluate the efficacy of PUR003 in assisting the treatment of asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebonormal saline for inhalation |
| PUR003 | Active comparator | Drug: PUR003PUR003 for inhalation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed written informed consent.
- Ability and willingness to return to the outpatient clinic for repeated clinic visits and complete all assessments.
- Adult male or female subject, 18-60 years of age.
- Stable, mild asthma not requiring any medical treatment other than short acting inhaled bronchodilators, as needed.
- No smoking within six months prior to entry
Key exclusion criteria (6 listed)
- History or presence of significant co-existing chronic diseases.
- History of asthma exacerbations or upper or lower respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) within four weeks of first visit.
- Pregnancy, breastfeeding.
- Abused alcohol or illicit drugs that required treatment.
- Participated in any other investigational drug evaluation within last 30 days.
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 |
|---|---|---|
| PUR003PUR003 for inhalation | Drug | PUR003 |
| PlaceboNormal saline for inhalation | Drug | placebo |
Primary outcome
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments.
Time frame: after three doses
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 22 Nov 2011.
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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.
Parameswaran Nair, MD, PhD principal investigator
St. Joseph's Healthcare Hamilton / Firestone Institute for Respiratory Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PUR003 in people with Asthma and Lung Diseases, run by Pulmatrix Inc. at 1 site 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 8 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 22 Nov 2011. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability of PUR003 as determined by incidence of adverse events (AEs); changes in physical examination, chest examination; pulmonary function; vital signs; electrocardiogram (ECG) and clinical laboratory assessments. (time frame: after three doses). 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 22 Nov 2011.