COPDPhase 2BREATH-1NCT00648245
Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD
A Phase 2 study testing BIO-11006 Inhalation Solution and BIO-11006 in people with COPD and Chronic Obstructive Pulmonary Disease, run by BioMarck Pharmaceuticals, Ltd. at 14 sites in United States.
Trial summary
The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- BIO-11006 Inhalation Solution and BIO-11006
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2008to Jul 2010
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable male or female outpatients, 45 years of age or older
- Active COPD with chronic bronchitis indicated by: (1) FEV1 = 40% to 70%, (2) FEV1/FVC ≤70%, (3)Chronic productive cough for 3 months in each of 2 successive years, and (4) Sputum (phlegm) production at least several days a week over the past 4 weeks
- Current or previous smoker with a 20-pack year history
Who cannot join
- Treatment with oral prednisone during the 6 weeks before enrollment
- Changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment
- Treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment
- Current asthma as determined by the investigator
- Change in smoking status during the previous 6 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Bay Pines VA Heatlhcare System
Bay Pines, Florida, 33744
Southeastern Lung Care
Decatur, Georgia, 30033
Duke University Medical Center
Durham, North Carolina, 27704
Pulmonary Associates
Glendale, Arizona, 85306
Baylor College of Medicine
Houston, Texas, 77030
Michael E. DeBakey VAMC
Houston, Texas, 77030
Greater Los Angeles Healthcare System
Los Angeles, California, 91343
University of Louisville
Louisville, Kentucky, 40202
North Carolina Clinical Research
Raleigh, North Carolina, 27607
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
Diagnostics Research Group
San Antonio, Texas, 78229
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Southeastern Research Center, LLC
Winston-Salem, North Carolina, 27103
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
About this study
Official title: A Phase 2a, Double Blind, Placebo Controlled, Multicenter, Dose Escalation Study to Evaluate the Safety and Efficacy of BIO 11006 Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.
Read the detailed description
COPD encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. The most common form of COPD is a combination of chronic bronchitis and emphysema. Many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. Clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. A treatment that inhibits mucus hypersecretion or blocks inflammation could benefit COPD patients with chronic bronchitis. The drug under evaluation in this study, BIO 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. In this study, BIO-11006 will be administered to COPD patients with chronic bronchitis, and the effects lung function will be assessed.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- BIO-11006 Inhalation Solution, Placebo, BIO-11006
- Keywords
- chronic obstructive pulmonary disease, COPD, Chronic bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIO-11006 Inhalation SolutionDrug
75 mg of BIO-11006 administered once per day for 21 days by nebulizer
BIO-11006 Inhalation SolutionDrug
150 mg of BIO-11006 administered once per day for 21 days by nebulizer
BIO-11006 Inhalation SolutionDrug
75 mg of BIO-11006 administered twice per day for 21 days by nebulizer
PlaceboDrug
Placebo given once daily for 21 days by nebulizer
BIO-11006Drug
125 mg BIO-11006 given twice per day for 21 days by nebulizer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: BIO-11006 Inhalation Solution |
| 2 | Experimental | Not described Receives: Drug: BIO-11006 Inhalation Solution |
| 3 | Experimental | Not described Receives: Drug: BIO-11006 Inhalation Solution |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
| 5 | Experimental | Not described Receives: Drug: BIO-11006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing adverse events, physical exams, vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis.
Measured: Throughout study
Secondary outcomes (1)
Efficacy of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing the change from baseline in pulmonary function.
Measured: Day 21 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Ted C Murphy, Ph.D, Study director, BioMarck Pharmaceuticals, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648245
- Sponsor's protocol ID
- BIM-CL-003
- Other IDs
- 5R44HL073591
- Acronym
- BREATH-1
- Status last verified
- Feb 2011
- First submitted
- 28 Mar 2008
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Double Blind, Placebo Controlled, Multicenter, Dose Escalation Study to Evaluate the Safety and Efficacy of BIO 11006 Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00648245
- Acronym / sponsor ID
- BREATH-1 / BIM-CL-003
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, COPD, Chronic bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- BioMarck Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Apr 2008 (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 symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.
Detailed description
COPD encompasses a number of chronic lung disorders that obstruct the airways and may be accompanied by airway hyperactivity. The most common form of COPD is a combination of chronic bronchitis and emphysema. Many of the signs and symptoms associated with chronic bronchitis are a result of airway mucus hypersecretion induced by chronic inflammation of the airways. Clinically, mucus hypersecretion results in impaired gas exchange and compromised mucociliary clearance, encouraging bacterial colonization and associated exacerbations. A treatment that inhibits mucus hypersecretion or blocks inflammation could benefit COPD patients with chronic bronchitis. The drug under evaluation in this study, BIO 11006, is a new therapeutic agent that may inhibit mucus secretion and may have important anti inflammatory properties. In this study, BIO-11006 will be administered to COPD patients with chronic bronchitis, and the effects lung function will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BIO-11006 Inhalation Solution |
| 2 | Experimental | Drug: BIO-11006 Inhalation Solution |
| 3 | Experimental | Drug: BIO-11006 Inhalation Solution |
| 4 | Placebo comparator | Drug: Placebo |
| 5 | Experimental | Drug: BIO-11006 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically stable male or female outpatients, 45 years of age or older
- Active COPD with chronic bronchitis indicated by: (1) FEV1 = 40% to 70%, (2) FEV1/FVC ≤70%, (3)Chronic productive cough for 3 months in each of 2 successive years, and (4) Sputum (phlegm) production at least several days a week over the past 4 weeks
- Current or previous smoker with a 20-pack year history
Key exclusion criteria (5 listed)
- Treatment with oral prednisone during the 6 weeks before enrollment
- Changed inhaled corticosteroid dose or long acting bronchodilator dose during the 6 weeks before enrollment
- Treatment with oxygen (with the exception of night time oxygen) during the 6 weeks before enrollment
- Current asthma as determined by the investigator
- Change in smoking status during the previous 6 months
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 |
|---|---|---|
| BIO-11006 Inhalation Solution75 mg of BIO-11006 administered once per day for 21 days by nebulizer | Drug | 1 |
| BIO-11006 Inhalation Solution150 mg of BIO-11006 administered once per day for 21 days by nebulizer | Drug | 2 |
| BIO-11006 Inhalation Solution75 mg of BIO-11006 administered twice per day for 21 days by nebulizer | Drug | 3 |
| PlaceboPlacebo given once daily for 21 days by nebulizer | Drug | 4 |
| BIO-11006125 mg BIO-11006 given twice per day for 21 days by nebulizer | Drug | 5 |
Primary outcome
Safety of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing adverse events, physical exams, vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis.
Time frame: Throughout study
1 secondary outcome
Efficacy of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing the change from baseline in pulmonary function.
Time frame: Day 21 of the study
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 10 Feb 2011.
- Click here for more information about the sponsor of this studyLink 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.
Ted C Murphy, Ph.D study director
BioMarck Pharmaceuticals, Ltd.
14 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 BIO-11006 Inhalation Solution and BIO-11006 in people with COPD and Chronic Obstructive Pulmonary Disease, run by BioMarck Pharmaceuticals, Ltd. at 14 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?
The sponsor lists 3 inclusion and 5 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 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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. 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?
Safety of BIO-11006 when administered once or twice daily for 21 days to subjects with COPD by assessing adverse events, physical exams, vital signs, pulmonary function, 12 lead electrocardiogram, clinical blood chemistries, hematology, and urinalysis. (time frame: Throughout study). 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 10 Feb 2011.