Pulmonary DiseaseINSPIRENCT01855659
A Single-center Study to Assess Peak Inspiratory Flow (PIF) in Different Stages' COPD Patients by Using the In-check Method.
An observational study of Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Pulmonary Disease
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients belonging in Stages II, II, IV
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
7th Pulmonary Dept, Athens Chest Hospital
Athens, Mesogion Ave. 152, Athens 11527
About this study
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
Read the detailed description
This study will assess the inspiratory flow rates at high levels of resistance in different stages of COPD patients. PIF will be measured by in-check method.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient uses when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient use when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
- All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient use when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two Accurately measures oral inspiratory flow rate (peak and sub-maximal) in order to assess suitability for inhaled medication
- Measures nasal inspiratory flow for assessing nasal airway patency
- Assesses response to nasal provocation
- Allows home monitoring of Peak Nasal Inspiratory Flow (PNIF)
- Easy to use, clean and reset, the In-Check helps patients maintain their respiratory health.
- High-quality medical-grade stainless steel and plastic construction
- Sterilizable plastic mouthpiece accepts different mask sizes
- Simple enough for home patient use, rugged enough for routine clinic use.
- Conditions
- Pulmonary Disease
- Keywords
- Lung diseases,, Obstructive,, Peak Inspiratory Flow, [C08.381.495.389]
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Patients who are stratified in the subgroups of COPD based on the severity: stages II, III, IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIF measurements in COPD
Values of PIF measurement in COPD stages' subgroups
Measured: 0 (baseline)
Secondary outcomes (1)
PIF measurement in COPD per age and gender
Values of PIF measurement in COPD patients per age and gender
Measured: 0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eleftherios Zervas, M.D, Study chair, Coordinator of Asthma Working Group of Hellenic Thoracic Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855659
- Sponsor's protocol ID
- 2013-HAL-EL-36
- Acronym
- INSPIRE
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 914724Malik 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.
PubMed 1218939Potter 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.
PubMed 5547281Schwela 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.
PubMed 10939084Singh 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.
PubMed 12699215Njoku 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.
PubMed 15267038Quanjer 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.
PubMed 9098701Elebute 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.
PubMed 5134061Onadeko 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.
PubMed 6087636
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study to Assess Peak Inspiratory Flow (PIF) in Different Stages' COPD Patients by Using the In-check Method.
- ClinicalTrials.gov ID
- NCT01855659
- Acronym / sponsor ID
- INSPIRE / 2013-HAL-EL-36
- Conditions
- Pulmonary Disease
- Keywords
- Lung diseases,, Obstructive,, Peak Inspiratory Flow, [C08.381.495.389]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will assess the inspiratory flow rates at high levels of resistance in different stages of COPD patients. PIF will be measured by in-check method.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient uses when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient use when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two years.
Commonly used for Asthma patients, the In-Check Oral Inspiratory Flow Meter is a portable hand-held inspiratory flow meter that provides an assessment of the speed of inhalation. The In-Check Oral measures inspiratory flow between 30 and 370 L/min, inspiratory flow is thought of by physicians as a sensitive marker for Chronic Obstructive Pulmonary Disease (COPD) screening. The In-Check Oral works when a patient inhales through the mouth, this will cause air to be drawn through the meter and a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale. The Standard In-Check Oral inspiratory flow meter can measure inspiratory flow rates in the range 30 to 370 l/min, with an accuracy of +/- 10% or 10 l/min (whichever is the greater). (A Low Range In-Check Oral Inspiratory flow meter is available by special request, measuring between 15 and 120 l/min).
- All In-Check Oral meters are calibrated using an ATS pulmonary waveform generator, and the product complies with the Australian and New Zealand standards for back pressure in flow meters. As with any inhalation device checking for loose foreign objects is important. The transparent body of the In-Check Oral meter is designed to allow a visual inspection before use. The meter is manufactured from medical grade components, and is suitable for multiple patient use when cleaned appropriately between patients. The expected life of the In-Check Oral, in normal use, is two Accurately measures oral inspiratory flow rate (peak and sub-maximal) in order to assess suitability for inhaled medication
- Measures nasal inspiratory flow for assessing nasal airway patency
- Assesses response to nasal provocation
- Allows home monitoring of Peak Nasal Inspiratory Flow (PNIF)
- Easy to use, clean and reset, the In-Check helps patients maintain their respiratory health.
- High-quality medical-grade stainless steel and plastic construction
- Sterilizable plastic mouthpiece accepts different mask sizes
- Simple enough for home patient use, rugged enough for routine clinic use.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | –Patients who are stratified in the subgroups of COPD based on the severity: stages II, III, IV |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients belonging in Stages II, II, IV
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PIF measurements in COPD
Time frame: 0 (baseline)
Values of PIF measurement in COPD stages' subgroups
1 secondary outcome
PIF measurement in COPD per age and gender
Time frame: 0 (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
- Background: PubMed 914724Melissinos 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.
- Background: PubMed 1218939Malik 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.
- Background: PubMed 5547281Potter 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.
- Background: PubMed 10939084Schwela 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.
- Background: PubMed 12699215Singh 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.
- Background: PubMed 15267038Njoku 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.
- Background: PubMed 9098701Quanjer 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.
- Background: PubMed 5134061Elebute 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.
- Background: PubMed 6087636Onadeko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleftherios Zervas, M.D study chair
Coordinator of Asthma Working Group of Hellenic Thoracic Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIF measurements in COPD (time frame: 0 (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855659, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2013.