Efficacy and Safety of a Sore Throat Lozenge Containing Lidocaine and Cetylpyridinium Chloride in...
Sore Throat Due to a Common ColdThis study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (CPC) 2 mg lozenge with a single dose of a lidocaine 1 mg + CPC 2 mg lozenge in the treatment of sore throat due to a common cold.
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections
BronchiolitisRespiratory Syncytial Virus InfectionsThe purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.
Phase 4 Study - Mucinex D as Adjunct Therapy
Acute Respiratory InfectionBronchitis1 moreThe objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
Upper Respiratory Tract InfectionsThe purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower...
Upper Respiratory Tract InfectionLower Respiratory Tract InfectionRSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
InfectionThe objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.
Vitamin D for Sickle-cell Respiratory Complications
Sickle Cell DiseaseVitamin D Deficiency3 moreThis study aims to answer the question whether oral vitamin D supplementation can decrease lung complications in children and adolescents with sickle cell disease. Lung complications are the leading causes of morbidity and of death in sickle cell disease. Infections and increased inflammation play important roles in the development of the lung problems in sickle cell disease. Emerging evidence shows that vitamin D helps the immune system to fight infection and to control inflammation and could potentially help prevent respiratory complications in patients with sickle cell disease. The investigators hypothesize that oral vitamin D3, 100,000 IU (2.5 mg), given once a month to a group of children and adolescents with sickle cell disease, will reduce the rate of respiratory events (infection, asthma exacerbation and acute chest syndrome) compared to the rate in a group given standard dose oral vitamin D3, 12,000 IU (0.3 mg) given once a month. Funding Source - U.S. Food & Drug Administration, Office of Orphan Products Development
Effect of Vaccination in Patients With Recurrent Respiratory Papillomatosis
Squamous Papilloma of the LarynxVaccines against human papillomaviruses are now commercially available. One of the commercial vaccine contains antigens of both LR HPV types which cause virtually all cases of RRP. Clinical trials have documented the safety and immunogenicity of this vaccine as well as its effectiveness in prevention of incident and persistent infection of the vaccinal types as well as a development of lesions caused by these types. After vaccination the antibodies level increases dramatically and the high levels of antibodies are present in the blood still after 6 years. Furthermore, the neutralization antibodies to the vaccinal antigens have been detected in the cervical mucus of vaccinated women. The preliminary data are now available showing the presence of HPV-specific antibodies in the oral cavity in women after vaccination. The level of antibodies has been dependent on time since vaccination.
M7824 in People With Recurrent Respiratory Papillomatosis
Recurrent Respiratory PapillomatosisRespiratory Papillomatosis3 moreBackground: Programmed cell death protein 1 (PD-L1) is a protein on the surface of cells. It regulates if a cell can be killed by immune system cells. It is thought to be able to affect the immune system response to diseased cells like those infected with a virus. The molecule M7824 interferes with the activity of PD-L1. It could help the immune system kill cells infected with a virus . Since recurrent respiratory papillomatosis is caused by a virus infection, this molecule could help. Objective: To see if M7824 works in treating recurrent respiratory papillomatosis. Eligibility: Adults ages 18 years or older with recurrent respiratory papillomatosis Design: Participants will be screened with: Medical history Physical exam Blood and pregnancy tests Endoscopy procedure in clinic. A small tube with a camera will look at the inside of the nose, throat, larynx, and upper windpipe. Some participants will also be screened with a chest scan. At the start of the study, participants will: Have a sedated endoscopy procedure where biopsies will be taken. Have blood tests. Have apheresis. Blood will be collected by a tube in an arm vein. A machine will remove white blood cells. The rest of the blood will be returned into an arm vein. Fill out a voice questionnaire. Participants will get the study molecule into a vein over about 1 hour. They will get it every other week for up to 12 weeks. Participants will repeat screening and starting procedures throughout the study. They will also review side effects and any medicine they are taking. When they are done with the study treatment, participants will be evaluated by repeating the study procedures. They may be evaluated periodically until their disease progresses.
Avelumab for People With Recurrent Respiratory Papillomatosis
Recurrent Respiratory PapillomatosisJuvenile Laryngeal Papilloma4 moreBackground: Recurrent respiratory papillomatosis (RRP) is a rare disease caused by human papillomavirus. It can cause voice changes, airway compromise, pulmonary lesions, and cancers. Programmed death-ligand 1 (PD-L1) is a protein on cells. It may be able to stop or decrease the immune system s response to viruses such as human papillomavirus. The drug Avelumab interferes with the activity of PD-L1. Researchers want to see if Avelumab treats RRP and study its side effects. Objective: To see if Avelumab works in treating RRP and is safe. Eligibility: People ages 18 and older with aggressive RRP that has not responded to available treatments Design: Participants will be screened with: Medical history Previously collected tumor tissue Physical exam Blood, urine, and heart tests Endoscopy procedure: A small tube with a camera is used to look in the nose, throat, larynx, and upper windpipe. Before starting treatment, participants will have: Endoscopy under anesthesia. A sample of papilloma will be taken. Voice handicap questionnaire Computed tomography (CT) scans Apheresis: An intravenous (IV) is inserted into an arm vein. White blood cells are separated from the rest of the blood and stored for research. The rest of the blood is returned through the same IV or one in the other arm. Participants will get the study drug by IV every 2 weeks for up to 12 weeks. Participants will repeat the previous tests throughout the study. If they respond to treatment, participants will be evaluated every 6 weeks (3 times), then every 12 weeks (3 times), then every 26 weeks (2 times) until their disease progresses. Participants will be evaluated 30 days after their last infusion. They will then be contacted annually.