Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2011-07-14
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
\- Parainfluenza is a virus that can cause infections in people. Most people infected with this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common cold). Some people, especially those with a weakened immune system, get very sick from this virus. They may have difficulty breathing or develop lung infections. Currently, there are no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go away faster. Researchers are interested in testing DAS181 to see if it is safe and effective against parainfluenza.
Objectives:
\- To test the safety and effectiveness of DAS181 as a treatment for parainfluenza.
Eligibility:
\- Individuals at least 18 years of age who have the parainfluenza virus and have developed symptoms within the past 10 days.
Design:
* Participants will be screened with a physical exam, medical history, and questions about symptoms and activity levels. Participants will also have a lung function test and provide blood and nasal fluid samples.
* DAS181 is an inhaled medication, and everyone will receive a study medication inhaler. Participants will receive either DAS181 or a placebo through the inhaler. They will take it once every day for 5 days.
* Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide blood and nasal fluid samples and have a lung function test.
* Participants who still have the virus in their system on Day 28 will return to the clinic on Day 42 for more tests. Participants who still have the virus in their system on Day 42 will return to the clinic on Day 56 for more tests.
* Participants will have followup visits 6 months and 1 year after the start of the study.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This exploratory randomized double-blind Phase 2 study will assess the safety and tolerability, and explore the efficacy of DAS181 versus placebo for the treatment of parainfluenza. Thirty eligible patients diagnosed with parainfluenza will be randomized in a 2:1 allocation to receive either DAS181-F02 formulation (10 mg times 5 days) or placebo. Subjects will be followed on Study Days 0, 2, 4, 7, 10, 14, 28, 180, and 365 with a series of clinical, pulmonary function, functional status, virologic, and safety assessments.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
DAS181
DAS181
20 mg per day of DAS181-FO3 for 5 days
2
Placebo
Placebo
20 mg per day of Lactose for 5 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DAS181
20 mg per day of DAS181-FO3 for 5 days
Placebo
20 mg per day of Lactose for 5 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Positive culture, DFA, PCR or other clinical assay for parainfluenza
3. Symptomatic upper or lower respiratory tract disease (e.g., pharyngitis, cough, tracheobronchitis, bronchiolitis, pneumonia). Fever alone is not sufficient.
4. Onset of illness within the last 10 days
5. Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of informed consent through Study Day 28 of the study. At least 1 of the methods of contraception should be a barrier method
6. Willingness to have samples stored
Exclusion Criteria
2. Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
3. Mechanical ventilation, acute respiratory distress, or otherwise unable to tolerate the drug delivery device (Cyclohaler)
4. Allergy or history of allergy to milk or lactose
5. Previous or current history of asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication
6. Any significant findings in the patient s medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard T Davey, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Henrickson KJ. Parainfluenza viruses. Clin Microbiol Rev. 2003 Apr;16(2):242-64. doi: 10.1128/CMR.16.2.242-264.2003.
Weintrub PS, Sullender WM, Lombard C, Link MP, Arvin A. Giant cell pneumonia caused by parainfluenza type 3 in a patient with acute myelomonocytic leukemia. Arch Pathol Lab Med. 1987 Jun;111(6):569-70.
Apalsch AM, Green M, Ledesma-Medina J, Nour B, Wald ER. Parainfluenza and influenza virus infections in pediatric organ transplant recipients. Clin Infect Dis. 1995 Feb;20(2):394-9. doi: 10.1093/clinids/20.2.394.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11-I-0205
Identifier Type: -
Identifier Source: secondary_id
110205
Identifier Type: -
Identifier Source: org_study_id