PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

Respinova

Status: Completed

Conditions: COPD

Treatments: Drug: Nebulizer & Albuterol 0.5ml; Device: Pulsehaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01187589

PLS-02

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups

Pulsehaler

Experimental group

Description:

Fully operational Pulsehaler, with protocol enabled

Treatment:

Device: Pulsehaler

Drug: Nebulizer & Albuterol 0.5ml

Nebulizer

Active Comparator group

Description:

Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active

Treatment:

Drug: Nebulizer & Albuterol 0.5ml