PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187589
• Other study ID #: PLS-02
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: September 22, 2011
• Start date: December 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Respinova LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Pulsehaler

Drug:
• Nebulizer & Albuterol 0.5ml
Albuterol aerosolized by a nebulizer

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center Nuclear Medicine Institute	Tzrifin

Sponsors (1)

Lead Sponsor	Collaborator
Respinova LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung deposition	Lung deposition of the albuterol-containing aerosol	1 hour	No
Primary	Pulmonary functions	Pulmonary function tests by spirometry	1 hour	No
Secondary	Dyspnea	Dyspnea measured by the modified Borg scale	1 hour	No