A Single-center Study to Assess Peak Inspiratory Flow (PIF) in Different Stages' COPD Patients by Using the In-check Method.

NCT01855659 | Completed

• 1 other identifier: 2013-HAL-EL-36
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Peak Inspiratory Flow Rate (PIFR) is defined by the fastest flow rate noted during the inspiratory cycle. Inhaled medication plays an important role in the treatment of chronic obstructive pulmonary disease (COPD), with dry powder inhalers (DPIs) increasingly replacing metered dose inhalers (MDIs). DPIs are interesting as they do not require the need for coordinate actuation of the MDI device with inhalation or the use of a large spacer device 1-3. Several DPIs are available for the administration of inhaled corticosteroids, as well as bronchodilators, with each of them corresponding to a different type of inhaler (e.g. Diskus®, Turbuhaler®, Aeroliser®, etc.). During the inspiratory effort the patient generates a pressure drop with a consequent airflow across the DPI. This inspiratory flow has to be high enough to disaggregate and adequately disperse the drug powder into an aerosol cloud of drug particles and to guarantee an optimal deposition of the medication in the lung. Such peak inspiratory flows (PIFs) are not only dependent on a patient's inhalation effort but also on the internal resistance of the device. It has been shown that optimal deposition of medication with DPIs is not achieved in some patients with low inspiratory flow rates, such as children or patients with COPD, especially during acute exacerbations. In such conditions the use of a DPI with low internal resistance has been suggested, ensuring an optimal deposition despite the lower flow rate. In addition, many clinicians are nowadays confronted with an important number of COPD patients who are aged \>70 yrs

Conditions

Pulmonary Disease

Keywords

Lung diseases,; Obstructive,; Peak Inspiratory Flow; [C08.381.495.389]

Outcome Measures

Primary Outcomes (1)

• PIF measurements in COPD

  Values of PIF measurement in COPD stages' subgroups

  0 (baseline)

Secondary Outcomes (1)

• PIF measurement in COPD per age and gender

  0 (baseline)

Study Arms (1)

COPD patients

Patients who are stratified in the subgroups of COPD based on the severity: stages II, III, IV

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients belonging in Stages II, II, IV

You may qualify if:

• COPD patients (Global Initiative of Chronic Lung Disease (GOLD) definition
• COPD stage II, III, IV
• Patients who are followed in Outpatients' Unit
• Patients \>50 years of age
• Patients who accept PIF to be measured using the In-Check Inhaler
• Patients who have signed the Informed Consent
• Patients who will comply with study demands and procedures

You may not qualify if:

• COPD stage I patients
• Patients who are hospitalized
• Patients \<50 years of age
• Patients who do not accept PIF to be measured using the In-Check Inhaler
• Patients who have not signed the Informed Consent
• Patients who face problems in order to comply with study demands and procedures

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

7th Pulmonary Dept, Athens Chest Hospital

Athens, Mesogion Ave. 152, Athens 11527, Greece

Location

Related Publications (9)

• Melissinos CG, Mead J. Maximum expiratory flow changes induced by longitudinal tension on trachea in normal subjects. J Appl Physiol Respir Environ Exerc Physiol. 1977 Sep;43(3):537-44. doi: 10.1152/jappl.1977.43.3.537.

  PMID: 914724 BACKGROUND

• Malik SK, Jindal SK, Jindal V, Bansal S. Peak expiratory flow rate in healthy adults. Indian J Chest Dis. 1975 Oct;17(4):166-71. No abstract available.

  PMID: 1218939 BACKGROUND

• Potter WA, Olafsson S, Hyatt RE. Ventilatory mechanics and expiratory flow limitation during exercise in patients with obstructive lung disease. J Clin Invest. 1971 Apr;50(4):910-9. doi: 10.1172/JCI106563.

  PMID: 5547281 BACKGROUND

• Schwela D. Air pollution and health in urban areas. Rev Environ Health. 2000 Jan-Jun;15(1-2):13-42. doi: 10.1515/reveh.2000.15.1-2.13.

  PMID: 10939084 BACKGROUND

• Singh V, Khandelwal R, Gupta AB. Effect of air pollution on peak expiratory flow rate variability. J Asthma. 2003 Feb;40(1):81-6. doi: 10.1081/jas-120017210.

  PMID: 12699215 BACKGROUND

• Njoku CH, Anah CO. Reference values for peak expiratory flow rate in adults of African descent. Trop Doct. 2004 Jul;34(3):135-40. doi: 10.1177/004947550403400303.

  PMID: 15267038 BACKGROUND

• Quanjer PH, Lebowitz MD, Gregg I, Miller MR, Pedersen OF. Peak expiratory flow: conclusions and recommendations of a Working Party of the European Respiratory Society. Eur Respir J Suppl. 1997 Feb;24:2S-8S. No abstract available.

  PMID: 9098701 BACKGROUND

• Elebute EA, Femi-Pearse D. Peak flow rate in Nigeria: anthropometric determinants and usefulness in assessment of ventilatory function. Thorax. 1971 Sep;26(5):597-601. doi: 10.1136/thx.26.5.597.

  PMID: 5134061 BACKGROUND

• Onadeko BO, Iyun AO, Sofowora EO, Adamu SO. Peak expiratory flow rate in normal Nigerian children. Afr J Med Med Sci. 1984 Mar-Jun;13(1-2):25-32.

  PMID: 6087636 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Eleftherios Zervas, M.D

  Coordinator of Asthma Working Group of Hellenic Thoracic Society

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 16, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-05

Locations

GR (1)