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Completed

NCT Number: NCT01187589

PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assaf Harofe Medical Center Nuclear Medicine Institute

Tzrifin, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsehaler

Device

Nebulizer & Albuterol 0.5ml

Drug

Albuterol aerosolized by a nebulizer

Primary outcomes

  1. Lung deposition

    Time frame: 1 hour

    Lung deposition of the albuterol-containing aerosol

  2. Pulmonary functions

    Time frame: 1 hour

    Pulmonary function tests by spirometry

Secondary outcomes

  1. Dyspnea

    Time frame: 1 hour

    Dyspnea measured by the modified Borg scale

Sponsors and collaborators

Lead sponsor

Respinova LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2010
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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