PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187589

Enrollment

Registered

2010-08-24

Start date

2010-12-31

Completion date

2011-09-30

Last updated

2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients

Interventions

DEVICEPulsehaler

DRUGNebulizer & Albuterol 0.5ml

Albuterol aerosolized by a nebulizer

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year * Post-bronchodilator FEV1/FVC \< 0.7 * Post-bronchodilator FEV1 in the range 30% - 70% predicted * Age: 40 years or older * Patient signed the informed consent form

Exclusion criteria

* Pneumothorax in the past, per anamnesis. * Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive. * Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher * Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months * Other severe systemic disease * Non-cooperative or non-compliant patient

Design outcomes

Primary

Measure	Time frame	Description
Lung deposition	1 hour	Lung deposition of the albuterol-containing aerosol
Pulmonary functions	1 hour	Pulmonary function tests by spirometry

Secondary

Measure	Time frame	Description
Dyspnea	1 hour	Dyspnea measured by the modified Borg scale

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026