Clinical trials: Exposure, Inhalation
Anthrax
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
The goal of this observational study is to evaluate the safety and clinical benefit of two doses of CYFENDUS vaccine when used with the concurrent recommended antibacterial regimen for post-exposure prophylaxis to prevent…
- Trial name
- NCT07268612
- Testing
- CYFENDUS
- Volunteers
- 250 people
- Sponsor
- Emergent BioSolutions
COVID-19
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days.
- Trial name
- NCT04313023
- Testing
- PUL-042 Inhalation Solution
- Where
- 15 sites in United States
- Volunteers
- 217 people
- Sponsor
- Pulmotect, Inc.
Inhalational Anthrax
A Field Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Inhalational Anthrax Patients
This study will evaluate safety and clinical benefit of AIGIV used for treatment of patients with inhalational anthrax. This study will be implemented only in the event of a major anthrax exposure event.
- Trial name
- NCT03569553
- Testing
- AIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Healthy
A Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a…
- Trial name
- NCT06340581
- Testing
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetics, Epinephrine
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
To assess the drug exposure profile in systemic circulation of Primatene Mist by inhalation, versus Epinephrine by intramuscular injection, and ProAir HFA by inhalation in healthy adults.
- Conditions
- Pharmacokinetics, Epinephrine, Albuterol, Asthma
- Trial name
- NCT04207840
- Testing
- Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL), Albuterol Sulfate (0.09 mg/inhalation)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure
The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study).
- Trial name
- NCT06746064
- Testing
- CHF10073 (Part 1 - SAD), CHF10073 (Part 2 - MAD), CHF10073 (Part 3)
- Where
- Belgium
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Allergic Rhinitis
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI).
- Trial name
- NCT00458835
- Testing
- Ciclesonide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Covis Pharma S.à.r.l.
Asthma
A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
- Trial name
- NCT00400608
- Testing
- ADVAIR HFA, ADVAIR DISKUS
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects
This is a double-blind, single dose (four inhalations), four-way cross over study in healthy subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics (PD) of Fluticasone Furoate, (FF)…
- Trial name
- NCT01691547
- Testing
- UMEC /VI, UMEC, VI
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler
This is an open-Label, Randomized Study in Healthy Normal Volunteers looking at exposure and effects (PK/PD) of multiple doses of Technosphere® Insulin (TI) using the Gen2C inhaler.
- Trial name
- NCT01490762
- Testing
- Technosphere Insulin Inhalation Powder using the Gen2C inhaler, Regular Human Insulin
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Mannkind Corporation
Pulmonary Disease, Chronic Obstructive
Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder.
- Trial name
- NCT03235726
- Testing
- CCI15106
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma, Diabetes Mellitus
A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics
This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled into the treatment phase of the trial.
- Trial name
- NCT00673621
- Testing
- Technosphere Insulin Inhalation Powder, Salbutamol (Albuterol), Methacholine chloride
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mannkind Corporation
Influenza, Human
Safety of Inhaled Zanamivir in Pregnancy
Zanamivir is a neuraminidase inhibitor that has demonstrated effectiveness against the pandemic H1N1 virus. Zanamivir was first authorized in Sweden in June 1999 and is approved in the European Union (EU) through mutual…
- Trial name
- NCT01462487
- Testing
- Treatment with zanamivir
- Volunteers
- 1 people
- Sponsor
- GlaxoSmithKline
Chronic Obstructive Pulmonary Disease
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane…
- Trial name
- NCT05477108
- Testing
- Treatment A (BGF MDI HFO with oral activated charcoal), Treatment B (BGF MDI HFA with oral activated charcoal)
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 1 Diabetes Mellitus
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
This is an Open-label, randomized study in Type 1 diabetics looking at exposure and response (PK/PD) of TI using GEN2C Inhaler versus rapid acting analog.
- Trial name
- NCT01544881
- Testing
- Technosphere Insulin Inhalation Powder, Rapid Acting Analog
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Mannkind Corporation
Asthma
Evaluation of AZD8154 Concentrations in Blood
This study is intended to evaluate the systemic pharmacokinetic (PK) characteristics and the safety of AZD8154 following administration of the Monodose DPI formulation compared with the administration of the nebuliser suspension.
- Trial name
- NCT04480879
- Testing
- AZD8154 nebuliser, AZD8154 Monodose DPI presented in capsules
- Where
- Germany
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Obstructive Pulmonary Disease
A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) [Test] and hydrofluoroalkane…
- Trial name
- NCT05569421
- Testing
- Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Asthmatic
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder
The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is…
- Trial name
- NCT01738087
- Testing
- NEXThaler 100/6 mcg DPI, Flixotide Accuhaler 500 mcg, NEXThaler 200/6 mcg DPI
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COVID-19
Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
This is a Phase 2, randomized, double-blind, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19.
- Trial name
- NCT05639166
- Testing
- IBIO123
- Where
- 5 sites in South Africa, Ukraine
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Immune Biosolutions Inc
Healthy Volunteers
Pharmacokinetic Study in Healthy Volunteers
Phase 1 clinical trial to evaluate insulin exposure using different formulations of Technosphere Insulin Inhalation Powder using the Gen2 inhaler in healthy normal volunteers.
- Trial name
- NCT01365117
- Testing
- Technosphere® Insulin Inhalation Powder
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mannkind Corporation