PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Pulsehaler; Drug: Nebulizer & Albuterol 0.5ml

• Registration Number: NCT01187589
• Lead Sponsor: Respinova LTD

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2010-12
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pulsehaler	Pulsehaler	Fully operational Pulsehaler, with protocol enabled
Pulsehaler	Nebulizer & Albuterol 0.5ml	Fully operational Pulsehaler, with protocol enabled
Nebulizer	Nebulizer & Albuterol 0.5ml	Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active

Primary Outcome Measures

Name	Time	Method
Lung deposition	1 hour	Lung deposition of the albuterol-containing aerosol
Pulmonary functions	1 hour	Pulmonary function tests by spirometry

Secondary Outcome Measures

Name	Time	Method
Dyspnea	1 hour	Dyspnea measured by the modified Borg scale

Trial Locations

Locations (1)

Assaf Harofe Medical Center Nuclear Medicine Institute; 🇮🇱 Tzrifin, Israel