AsthmaPhase 1DAS181NCT01113034
A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
A Phase 1 study testing DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra) in people with Asthma and Bronchiectasis, run by Ansun Biopharma, Inc. at 1 site in United States.
Trial summary
The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Bronchiectasis
- What is being tested?
- DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 22 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A male or female subject must be 18 to 65 years of age.
- Except for underlying airway disease, subject must be in good health as determined by medical history, targeted physical examination based on medical history, and vital signs (that include temperature, blood pressure, heart rate, and pulse oximetry).
- Subject must be able to verbalize understanding of the informed consent form, verbalize willingness to complete all study procedures, and provide written informed consent (sign the informed consent form).
- Subject must be willing to commit to participating in both the initial and cross-over stages of the study.
- Dipstick analysis of subject's urine specimen must be negative or show only trace amounts of glucose, hemoglobin, and protein. A menstruating female who tests positive for urine hemoglobin may be retested.
- Subject must have blood screening test results that are within normal limits (according to standards set within the Clinical Center) for the following tests: alanine transaminase (ALT), alkaline phosphatase (ALKP), activated partial thromboplastin time (APTT), and aspartate transaminase (AST).
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- Subject must have hematologic screening tests that are within a specified range, including hemoglobin of 10.9 g/dL, white blood cell count 2500/mm3, and platelet count 125,000/mm3 (all <grade 1 on DAIDS severity scale).
- A female subject must be post-menopausal (1 year without menses), have been surgically sterilized, practice abstinence, or use an effective method of birth control that may include an intrauterine device, spermicide, barrier, and hormonal contraception. A female subject must also have a negative serum test for pregnancy during the Screening period, and a negative urine test for pregnancy on the first day of drug or placebo administration.
- Asthma Subjects:
- Subject must have a clinically established diagnosis of asthma based upon a history of episodic symptoms of airway obstruction or airway hyper-responsiveness (i.e., wheezing).
- Subject must have a documented increase in FEV1 or forced vital capacity (FVC) 12% (and at least 200 mL) from baseline after inhaling a short-acting bronchodilator; or a PC20FEV1 response to methacholine (i.e., the concentration of methacholine that produces a 20% decrease in FEV1 from the post-saline value during the methacholine challenge) of 8 mg/mL.
- At the time of study enrollment, subject's asthma has been well-controlled for at least the past 3 months, as defined by the following:
- Daytime symptoms occur 2 days per week
- Normal daily activity is not limited by asthma
- Nocturnal symptoms/nighttime awakenings 2 times/month
- FEV1 80% predicted
- Use of short-acting beta-agonist 2 days/week
- Exacerbations requiring oral corticosteroids occur 2 times/year
- There has been no change in asthma medication dose or regimen within 3 months of study enrollment
- Not currently taking oral corticosteroids
- Bronchiectasis Subjects:
- Subject will be recruited from ongoing NIH natural history protocols (06-I-0217, 01-I-0202, and 09-I-0172) and/or the National Bronchiectasis Registry.
- Subject must have a pre-established diagnosis of bronchiectasis based on chest computed tomography (CT) scan findings within 12 months of enrollment (no diagnostic CT scans will be performed during the Screening phase of this study).
- Subject must not have overt allergic bronchopulmonary aspergillosis, cystic fibrosis, or primary ciliary dyskinesia.
- Subject's bronchiectasis is stable as defined by the following:
- Less than 2 acute exacerbations in the preceding 12 months and none in the preceding 4 weeks, with acute exacerbation defined as persistent (>24 hour) worsening of >3 respiratory symptoms associated with bacterial infection including: i. Cough ii. Dyspnea iii. Hemoptysis iv. Increased sputum purulence or volume v. Chest pain b. No change in antimicrobial regimen for at least 3 months before enrollment c. FEV1 80% predicted d. Use of short-acting beta-agonist 2 days/week for at least the past 3 months e. No baseline requirement for oxygen supplementation f. Ability to maintain oxyhemoglobin saturation of 90% during and after 6-minute walk test g. Not currently taking oral corticosteroids
Who cannot join
- Subject has received any investigational drug or vaccine within 4 weeks prior to study drug dosing, or is planning to participate in another investigational drug or vaccine trial prior to completion of this study.
- Subject is currently taking theophylline or oral corticosteroids.
- Subject is allergic to milk or milk products.
- Subject currently smokes tobacco or has smoked tobacco within 1 year prior to study enrollment.
- Subject has a baseline requirement for oxygen supplementation.
- Subject is unable to maintain an oxyhemoglobin saturation of 90% during and after 6-minute walk test.
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- The subject tests positive for human immunodeficiency virus (HIV), for hepatitis B virus (HBV), or hepatitis C virus (HCV).
- The subject's resting blood pressure is outside normal limits (defined as: systolic 90-140 mmHg; diastolic 50-90 mm Hg).
- The subject's heart rate is less than 45 or greater than 100 beats per minute at rest.
- The subject weighs less than 45 kg.
- The subject has a Body Mass Index of greater than 35 kg/m2.
- The subject has experienced an episode of acute upper respiratory tract infection, pneumonia, otitis, bronchitis, or sinusitis within 6 weeks of study enrollment.
- The subject has an oral temperature above 37.8°C (100°F).
- The subject has any surgical, medical, or laboratory condition that, in the judgment of the clinical investigator, might interfere with the safety, distribution, metabolism, or excretion of the drug.
- The subject has overt primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or cystic fibrosis.
- The subject has previous or current history of the following conditions: renal, hepatic, cardiac, hematologic (including sickle cell disease), muscular, neurological, metabolic, or immunological disorders, malignancy, hepatitis or cirrhosis, transplant recipients, HIV-infection, or other immunosuppressive illness, which could, in the opinion of the study investigators, compromise subject safety or interfere with the assessment of study drug safety.
- A female who is pregnant or breast-feeding.
- A subject who has received blood products within 6 months of study enrollment.
- The subject has donated or lost more than 500 mL of blood in the 3 months prior to screening.
- The subject has clinically significant medical or psychological conditions that would compromise the subject's safety, influence the results of the study, affect the subject's ability to participate in the study, or impair the subject's ability to provide informed consent.
- The subject has a history of alcoholism, drug dependence, or significant psychiatric illness within 2 years of study enrollment.
- The subject uses anticoagulant medications or drugs with known potential for hepatotoxicity as such agents could interfere with relevant safety assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.
Read the detailed description
This study will assess the safety of a new study drug called DAS181 (Fludase®). This study is being done with NexBio, Inc., the company that makes DAS181 (Fludase®). DAS181 is not approved by the Food and Drug Administration (FDA); however the FDA has given permission to use DAS181 in human studies. To date, DAS181 has been given to about 81 healthy people and has been well tolerated with no reported serious adverse reactions. This is the first experimental study to test if it is safe to use this drug in people with well-controlled asthma or bronchiectasis. DAS181 is not being given to treat asthma or bronchiectasis, but to learn if it is safe to use in people with well-controlled asthma or bronchiectasis. DAS181 is being developed as a medication to prevent and treat infections due to common respiratory viruses like influenza (including the pandemic H1N1 strain), parainfluenza, and other viruses. New drugs to treat respiratory viruses are needed because some currently available drugs are not effective against some types or strains of viruses. Drugs that are effective against respiratory viruses are especially important for people with asthma or bronchiectasis because these lung conditions increase the risk of serious complications due to respiratory virus infections. Making sure the new drug is safe in people with asthma or bronchiectasis is important because people with these lung conditions may have different side effects from a drug than people who don't have asthma or bronchiectasis. We plan to enroll 24 volunteers into the study: 12 persons with well-controlled asthma and 12 persons with bronchiectasis.
- Conditions
- Asthma, Bronchiectasis
- Being tested
- DAS181 dry powder, formulation F02, Respitose ML006 (DMV-Fonterra)
- Keywords
- Asthma, Bronchiectasis
- Medical subject headings
- Asthma, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAS181 dry powder, formulation F02Drug
10 mg delivered dose DAS181 in clear HPMC #3 Capsules
Respitose ML006 (DMV-Fonterra)Drug
Lactose monohydrate
| Study group | Role | What they receive |
|---|---|---|
| DAS181 Dry Powder 10 mg qd x 3 days | Active comparator | Not described Receives: Drug: DAS181 dry powder, formulation F02 |
| Lactose Placebo | Placebo comparator | Not described Receives: Drug: Respitose ML006 (DMV-Fonterra) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity profile: Unacceptable Serious Adverse Events
Measured: 6 weeks (up to 12 weeks)
Secondary outcomes (2)
Assessment of acute tolerability of DAS181 administration in subjects with well-controlled asthma or bronchiectasis, specifically with regard to airway obstruction (FEV1) and oxyhemoglobin saturation.
Measured: 6 weeks
Examine potential effects of DAS181 on underlying lung disease, i.e., as relates to airway hyperreactivity, mucus production, airway inflammation, frequency of acute exacerbations, and health related quality of life measurements.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startJul 2010
- Primary completion22 Aug 2011
- Study completion22 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ansun Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ronald Moss, MD, Study director, Ansun Biopharma, Inc.Kenneth Olivier, MD, MPH, LCID, NIAID, Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113034
- Sponsor's protocol ID
- DAS181 - 1 - 04, 10 - I - 0085
- Acronym
- DAS181
- Status last verified
- Jul 2010
- First submitted
- 27 Apr 2010
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Davey EL, Colombo RE, Fiorentino C, Fahle G, Davey RT Jr, Olivier KN, Kovacs JA. Pneumocystis colonization in asthmatic patients not receiving oral corticosteroid therapy. J Investig Med. 2017 Apr;65(4):800-802. doi: 10.1136/jim-2016-000381. Epub 2017 Feb 13.
PubMed 28193704Colombo RE, Fiorentino C, Dodd LE, Hunsberger S, Haney C, Barrett K, Nabha L, Davey RT Jr, Olivier KN. A phase 1 randomized, double-blind, placebo-controlled, crossover trial of DAS181 (Fludase(R)) in adult subjects with well-controlled asthma. BMC Infect Dis. 2016 Feb 1;16:54. doi: 10.1186/s12879-016-1358-9.
PubMed 26830468
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized Double-Blind Placebo-Crossover Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
- ClinicalTrials.gov ID
- NCT01113034
- Acronym / sponsor ID
- DAS181 / DAS181 - 1 - 04, 10 - I - 0085
- Conditions
- Asthma, Bronchiectasis
- Keywords
- Asthma, Bronchiectasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ansun Biopharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2010
- Primary completion
- 22 Aug 2011 (actual)
- Study completion
- 22 Aug 2011 (actual)
- First posted
- 29 Apr 2010 (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 primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.
Detailed description
This study will assess the safety of a new study drug called DAS181 (Fludase®). This study is being done with NexBio, Inc., the company that makes DAS181 (Fludase®). DAS181 is not approved by the Food and Drug Administration (FDA); however the FDA has given permission to use DAS181 in human studies. To date, DAS181 has been given to about 81 healthy people and has been well tolerated with no reported serious adverse reactions. This is the first experimental study to test if it is safe to use this drug in people with well-controlled asthma or bronchiectasis. DAS181 is not being given to treat asthma or bronchiectasis, but to learn if it is safe to use in people with well-controlled asthma or bronchiectasis. DAS181 is being developed as a medication to prevent and treat infections due to common respiratory viruses like influenza (including the pandemic H1N1 strain), parainfluenza, and other viruses. New drugs to treat respiratory viruses are needed because some currently available drugs are not effective against some types or strains of viruses. Drugs that are effective against respiratory viruses are especially important for people with asthma or bronchiectasis because these lung conditions increase the risk of serious complications due to respiratory virus infections. Making sure the new drug is safe in people with asthma or bronchiectasis is important because people with these lung conditions may have different side effects from a drug than people who don't have asthma or bronchiectasis. We plan to enroll 24 volunteers into the study: 12 persons with well-controlled asthma and 12 persons with bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAS181 Dry Powder 10 mg qd x 3 days | Active comparator | Drug: DAS181 dry powder, formulation F02 |
| Lactose Placebo | Placebo comparator | Drug: Respitose ML006 (DMV-Fonterra) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- A male or female subject must be 18 to 65 years of age.
- Except for underlying airway disease, subject must be in good health as determined by medical history, targeted physical examination based on medical history, and vital signs (that include temperature, blood pressure, heart rate, and pulse oximetry).
- Subject must be able to verbalize understanding of the informed consent form, verbalize willingness to complete all study procedures, and provide written informed consent (sign the informed consent form).
- Subject must be willing to commit to participating in both the initial and cross-over stages of the study.
- Dipstick analysis of subject's urine specimen must be negative or show only trace amounts of glucose, hemoglobin, and protein. A menstruating female who tests positive for urine hemoglobin may be retested.
Key exclusion criteria (22 listed)
- Subject has received any investigational drug or vaccine within 4 weeks prior to study drug dosing, or is planning to participate in another investigational drug or vaccine trial prior to completion of this study.
- Subject is currently taking theophylline or oral corticosteroids.
- Subject is allergic to milk or milk products.
- Subject currently smokes tobacco or has smoked tobacco within 1 year prior to study enrollment.
- Subject has a baseline requirement for oxygen supplementation.
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 |
|---|---|---|
| DAS181 dry powder, formulation F0210 mg delivered dose DAS181 in clear HPMC #3 Capsules | Drug | DAS181 Dry Powder 10 mg qd x 3 days |
| Respitose ML006 (DMV-Fonterra)Lactose monohydrate | Drug | Lactose Placebo |
Primary outcome
Safety and toxicity profile: Unacceptable Serious Adverse Events
Time frame: 6 weeks (up to 12 weeks)
2 secondary outcomes
Assessment of acute tolerability of DAS181 administration in subjects with well-controlled asthma or bronchiectasis, specifically with regard to airway obstruction (FEV1) and oxyhemoglobin saturation.
Time frame: 6 weeks
Examine potential effects of DAS181 on underlying lung disease, i.e., as relates to airway hyperreactivity, mucus production, airway inflammation, frequency of acute exacerbations, and health related quality of life measurements.
Time frame: 6 weeks
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 27 Mar 2019.
- Derived from this study: PubMed 28193704Davey EL, Colombo RE, Fiorentino C, Fahle G, Davey RT Jr, Olivier KN, Kovacs JA. Pneumocystis colonization in asthmatic patients not receiving oral corticosteroid therapy. J Investig Med. 2017 Apr;65(4):800-802. doi: 10.1136/jim-2016-000381. Epub 2017 Feb 13.
- Derived from this study: PubMed 26830468Colombo RE, Fiorentino C, Dodd LE, Hunsberger S, Haney C, Barrett K, Nabha L, Davey RT Jr, Olivier KN. A phase 1 randomized, double-blind, placebo-controlled, crossover trial of DAS181 (Fludase(R)) in adult subjects with well-controlled asthma. BMC Infect Dis. 2016 Feb 1;16:54. doi: 10.1186/s12879-016-1358-9.
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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.
Ronald Moss, MD study director
Ansun Biopharma, Inc.
Kenneth Olivier, MD, MPH, LCID, NIAID principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 DAS181 dry powder, formulation F02 and Respitose ML006 (DMV-Fonterra) in people with Asthma and Bronchiectasis, run by Ansun Biopharma, Inc. at 1 site 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 26 inclusion and 22 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 27 Mar 2019. 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 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 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 toxicity profile: Unacceptable Serious Adverse Events (time frame: 6 weeks (up to 12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113034, which also lists 2 linked publications.
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 27 Mar 2019.