Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01853540 · ClinicalTrials.gov registry record · Phase 1
Sildenafil for PNTM Infection
A Phase 1 study of Nontuberculous Mycobacterial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01853540 is a Phase 1 study of Nontuberculous Mycobacterial Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01853540, a Phase 1 study of Nontuberculous Mycobacterial Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of bacteria in the environment. Although PNTM infection is most common in people with lung diseases, it can also affect healthy people. It can be difficult to treat, and affects parts of the body other than the lungs. For example, PNTM may affect the cilia, the hair-like structures inside the nose and lungs that help move dirt and debris out of the body. * Ciliary beat frequency (CBF) is a measurement of how fast cilia move. People with PNTM infection have a lower CBF than healthy people. Nitric oxide (NO) is a gas in the body that may affect CBF. People with PNTM infection produce lower amounts of NO in their noses than healthy people. Researchers want to see if a drug called sildenafil can increase NO production and CBF. If sildenafil can improve these measurements, it may be a useful treatment for PNTM infection. Objectives: \- To study the effect of sildenafil on CBF and NO levels in people with PNTM infection. Eligibility: * Individuals at least 18 years of age who have PNTM infection. * Participants must be enrolled in a related National Institutes of Health study on bacterial infections. The study is Natural History, Genetics, Phenotype and Treatment of Mycobacterial Infections. Design: * Participants will be screened with a physical exam and medical history. They will also have heart and lung function tests, as well as tests of NO production in the nose. They will provide samples of sputum and cells from inside the nose. * Before the first study visit, participants will collect sputum samples for 24 hours. They will bring the samples to the study visit. * At the first study visit, participants will have heart and lung function tests, as well as tests of NO production in the nose. They will provide blood, urine, sputum, and nasal cell samples. They will also receive sildenafil tablets to take at home. * Participants will take sildenafil tablets three times
Conditions Studied
Interventions
- DRUG Sildenafil
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01853540
The ClinicalTrials.gov registry entry for NCT01853540 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nontuberculous Mycobacterial Infection appearing as the primary indexed condition, and to 1 intervention - of which Sildenafil is the first listed.
NCT01853540 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01853540 about?
NCT01853540 is a clinical study titled "Sildenafil for PNTM Infection". Background: * Pulmonary nontuberculous mycobacterial (PNTM) infection is caused by a common type of bacteria in the environment. Although PNTM infection is most common in people with lung diseases, it can also affect healthy people. It can be difficult to treat, and affects parts of the body other ...
What is the current status of trial NCT01853540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-01. Estimated completion is 2014-10.
What conditions does trial NCT01853540 study?
This clinical trial studies the following conditions: Nontuberculous Mycobacterial Infection.
What interventions are being tested in trial NCT01853540?
The interventions under investigation include: Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01853540?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01853540 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.