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

2014-08-27 03:14:06 | BioPortfolio

Summary

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

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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Asthma

Intervention

DAS181 dry powder, formulation F02, Respitose ML006 (DMV-Fonterra)

Location

NIH Clinical Center
Bethesda
Maryland
United States
20892

Status

Not yet recruiting

Source

NexBio, Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:06-0400

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