The Leaky Lung Test

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

NCT00669331

Bronchiectasis

COMPLETED PHASE3

A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device

NCT00730977

Healthy Bronchiectasis

COMPLETED PHASE1/PHASE2

High Dose Inhaled Mannitol Study

NCT01076491

Bronchiectasis

COMPLETED PHASE1/PHASE2

A Pilot Safety Study of Inhaled Dry Powder Mannitol in Acute Exacerbations of COPD

NCT00446667

COPD Exacerbation

WITHDRAWN PHASE1/PHASE2

Explorative Clinical Investigation to Investigate the Ability of PreciseInhale to Direct Regional Lung Targeting and Reduce the Degree of Throat Deposition and Subsequent Gastrointestinal Absorption in Healthy Volunteers After Inhalation of Test Drug Substances Via the PreciseInhale System

NCT04946630

Nebulizers and Vaporizers

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Allergy Reactive Airway Disease Lung Diseases, Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asthma

Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Subjects will be challenged with inhaled mannitol according to already approved protocols.

Controls

Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Subjects will be challenged with inhaled mannitol according to already approved protocols.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mannitol

Subjects will be challenged with inhaled mannitol according to already approved protocols.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aridol for bronchoprovocation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

1. \>5 pack year history of tobacco use or active smoking.
2. Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
3. History of significant renal insufficiency of liver disease
4. Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
5. Asthma subjects with a baseline FEV1\<65% predicted
6. Asthma subjects unwilling or unable to withhold medications prior to testing
7. Pregnant women.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes