A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis

NCT01113034 | Completed Phase 1 DMC

• 1 other identifier: DAS181 - 1 - 04, 10 - I - 0085
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.

Conditions

Asthma; Bronchiectasis

Keywords

Asthma; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity profile: Unacceptable Serious Adverse Events

  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.

  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.

  6 weeks

Study Arms (2)

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)

Interventions

DAS181 dry powder, formulation F02 DRUG

10 mg delivered dose DAS181 in clear HPMC #3 Capsules

DAS181 Dry Powder 10 mg qd x 3 days

Respitose ML006 (DMV-Fonterra) DRUG

Lactose monohydrate

Lactose Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ansun Biopharma, Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

NIH Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 28193704 DERIVED

• Colombo 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.

  PMID: 26830468 DERIVED

MeSH Terms

Conditions

Asthma; Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ronald Moss, MD

  Ansun Biopharma, Inc.

  STUDY DIRECTOR

• Kenneth Olivier, MD, MPH, LCID, NIAID

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 29, 2010
• Study Start: July 1, 2010
• Primary Completion: August 22, 2011
• Study Completion: August 22, 2011
• Last Updated: March 27, 2019

Record last verified: 2010-07

Locations

US (1)