Prospective evAluatIon foR Inhalation Devices Study (PAIR)
Multicenter, Prospective, Observational, Non Interventional Clinical Trial to Assess the Asthma and COPD Treatment by Inhalation Devices
ASTHMA:
Asthma is a chronic inflammatory disorder of the airways in which many different types of cells, and various cellular components. The chronic inflammation causes an increase of the over-responsiveness of the airways, which leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning hours. These episodes, usually associated with widespread but variable block the airway, which is usually reversible either spontaneously or by treatment.
Asthma is one of the most common chronic diseases worldwide, posing significant social burden in both children and adults. It is estimated that about 300 million people currently suffer from asthma. The incidence of asthma is universal regardless of the level of development of the country. There is evidence that over the last 20 years the prevalence has increased significantly, specially in pediatric populations.
COPD:
Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem. It is the fourth leading cause of chronic morbidity and mortality in the United States after heart disease, strokes and acute respiratory infections, while on an annual basis, the disease robs the lives of more than 3,000,000 people around us worldwide. The most worrying is that the impact has been steadily rising, and this dramatic increase in the frequency shows that by 2020 the disease will be the third leading cause of death. In Greece, 8.4% of the population suffers from COPD.
Smoking is the leading cause of COPD. However, not all smokers develop the clinical picture of COPD, suggesting that additional factors are involved in manifestation. Further investigation of risk factors for COPD, methods of reducing exposure to these agents and the molecular and cellular mechanisms involved in the pathogenesis remain a major area of research to develop effective treatments that will reduce or prevent the development the disease.
Studieoversigt
Detaljeret beskrivelse
ASTHMA TREATMENT:
As regards the pharmacological management of asthma, inhaled corticosteroids (eg budesonide, fluticasone and beclomethasone) underlying the maintenance therapy, while beta-2 agonists are the long-term preferred additional treatment. Other common medications are systemic corticosteroids, beta-2-agonist short duration (eg salbutamol) oral beta2-agonists, long-lasting, methylxanthines, converters leukotrienes, colors and anticholinergics.
The main clinical advantages of transport and deposition of the drug directly to the lungs associated with the safety and efficacy: the side effects associated with the systemic circulation zero, while high concentrations of the active substance can be directly attributed to the points of action. Furthermore, the onset of action of inhaled beta2-agonist is faster that of oral beta-2 agonist and the therapeutic response is achieved faster. Finally, require lower doses of the drug, due to the efficiency of this direct lungs, reducing the problems of poor absorption and metabolism by the liver.
COPD TREATMENT:
Effective management of COPD involves four steps: (1) assessment and monitoring of the disease, (2) minimize the risk factors, (3) stabilization of disease, and (4) the treatment of an exacerbation.
ELPENHALER:
A new multi-single dose inhaled dry powder (Elpenhaler ®) has been designed, developed and patented by the Elpen Pharmaceutical Co. Inc (Pikermi, Greece). The new inhaler is suitable for the performance of a range of drugs for asthma, such as budesonide, formoterol and fluticasone.
OTHER TREATMENT APPROACHES:
Most asthma medications are administered in the form of inhalers. There are various forms of devices that facilitate the administration of inhaled medications in young children. The correct use of inhalers drugs is very important for the treatment of asthma. If the patient does not understand the correct instructions, the drug is deposited satisfactorily lungs, ie organ must act, so there is no remission. Furthermore when the inhalers incorrectly used much of the drug remains in the oral cavity and the pharynx and therefore the patient is exposed to any adverse events drug while not treated properly asthma. Appropriate for patient inhaler should be chosen by the attending physician, after confirmation by pilot demonstration site at the clinic, the patient (depending on age) have understood and can apply the device user. A new study conducted by the Center for Capital allergies and respiratory diseases showed that 25% of asthmatic subjects reported that the inhaler was empty during an asthma attack. The reason: "There is no way for someone to see how much medicine has used the inhaler continues to blow air even when it is empty," says Bradley Chips, who was lead author of the study. To save your breath, look at the package leaflet number of inhaled doses contain.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Athens, Grækenland
- Evagelismos hospital
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Athens, Grækenland
- Private office
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Lamia, Grækenland
- General State hospital of Lamia
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Piraeus, Grækenland
- Private office
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Volos, Grækenland
- Private office
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Voula, Grækenland
- Asklipiion Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients (newly diagnosed or not) with asthma and / or COPD, who use correctly (according to the opinion of the responsible investigator) their device
- Male or female patients aged 18 years
- Patients with compliance to treatment
- Patients with compliance to the study procedures
- Patients who have signed the study participation consent form.
Exclusion Criteria:
- Patients who use incorrectly their inhalational devices
- Male or female patients under 18 years
- Patients who are non-compliant to their treatment for asthma and COPD
- Patients who are non-compliant to study procedures
- Patients who have not signed the study participation consent form.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
asthma, COPD
patients with asthma and COPD treated with inhalation devices
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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FSI-10 score
Tidsramme: 2 months treatment
|
FSI-10 questionnaire total score FSI-10 questionnaire score per question
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2 months treatment
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse Events Reporting
Tidsramme: 2 months treatment
|
Number of Adverse Events occured during study duration.
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2 months treatment
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Spyridon Papiris, MD, Professor, Professor of Pulmonology, Attikon University Hospital of Athens
- Ledende efterforsker: Athina Vlachou, MD, Private office
- Ledende efterforsker: Areti Xifteri-Nikolinati, MD, Messini, Greece
- Ledende efterforsker: Georgios Efraimidis, MD, Plmonology Hospital of Patras, Greece
- Ledende efterforsker: Nikolaos Harokopos, MD, General hospital of Pyrgos, Peloponnese, Greece
- Ledende efterforsker: Dionysia Kalampoka, MD, Private Office, Patras, Greece
- Ledende efterforsker: Athanasia Christara, MD, Private Office, Korinthos, Greece
- Ledende efterforsker: Emmanouel Fothiantakis, MD, Private Office, Chaidari, Athens, Greece
- Ledende efterforsker: Elias Kainis, MD, Sotiria Pulmonogy Hospital of Athens
- Ledende efterforsker: Adamantia Liapikou, MD, Sotiria Pulmonary Hospital of Athens
- Ledende efterforsker: Xenophon Agelidis, MD, Attikon Hospital
- Ledende efterforsker: Antonios Kopanakis, MD, Thriasio General Hospital, Greece
- Ledende efterforsker: Konstantina Houliara, MD, Private office, Patisia, Athens, Greece
- Ledende efterforsker: Helen Adamou, MD, Nea Filadelfia, Athens, Greece
- Ledende efterforsker: George Kalfountzos, MD, Private office, Larissa, Greece
- Ledende efterforsker: Athanasios Pitenis, MD, Private Office, Grevena, Greece
- Ledende efterforsker: Eugeneia Karyanou, MD, Private Office, Kaisariani, Athens, Greece
- Ledende efterforsker: Georgia Kotantoula, MD, Private Office, Gerakas, Attika, Greece
- Ledende efterforsker: Evangelos Bourantzis, MD, Private office, Athens, Greece
- Ledende efterforsker: Konstantinos Marosis, MD, Sotiria Pulmonary Hospital of Athens
- Ledende efterforsker: Harilaos Lambrakis, MD, Sotiria Pulmonary Hospital of Athens
- Ledende efterforsker: Anastasios Palamidas, MD, Sotiria Pulmonary Hospital of Athens
- Ledende efterforsker: Dimitrios Zois, MD, General Hospital of Karditsa, Greece
- Ledende efterforsker: Maria Varouha, MD, Private office, Rethymno, Crete, Greece
- Ledende efterforsker: Karmen Stahouli, MD, Hatzikosta Hospital of Ioannina, Greece
- Ledende efterforsker: Peter Oikonomides, MD, General Hospital of Filiata, Thesprotia, Greece
- Ledende efterforsker: George Balasoulis, MD, Private office, Thessaloniki, Greece
- Ledende efterforsker: Konstantinos Porpodis, MD, Private office, Thessaloniki, Greece
- Ledende efterforsker: Despina Melemeni, MD, Sismanogleio Hospital of Athens, Greece
- Ledende efterforsker: Andreas Stratis, MD, Private office, Greece
- Ledende efterforsker: Efrosini Manali, MD, Attikon University Hospital of Athens, Greece
- Ledende efterforsker: Theodora Tsiounta, MD, Theageneio oncology hospital of Thessaloniki, Greece
- Ledende efterforsker: Anna Gavriilidou, MD, Papageorgiou hospital of Thessaloniki, Greece
- Ledende efterforsker: Athanasia Pataka, MD, Papanikolaou General hospital of Thessaloniki, Greece
- Ledende efterforsker: Chrysavgi Terovitou, MD, General hospital of Kavala, Greece
- Ledende efterforsker: Elisavet Christina Filippidou, MD, General hospital of Kavala, Greece
- Ledende efterforsker: Paschalis Kakavelas, MD, Private office, Piraeus, Greece
- Ledende efterforsker: Nikolaos Manolakoglou, MD, Private office, Kalamaria, Thessaloniki, Greece
- Ledende efterforsker: Evangelia Tsikrika, MD, General hospital of Veroia, Greece
- Ledende efterforsker: Athanasios Papandreou, MD, Private office, Orestiada, Greece
- Ledende efterforsker: Vasilios Adamidis, MD, Private office, Kozani, Greece
- Ledende efterforsker: Paraskevi Tsafaridou, MD, Private office, Thessaloniki, Greece
- Ledende efterforsker: Maria Katertzi, MD, Private office, Moudania, Thessaloniki, Greece
- Ledende efterforsker: Pashalia Tsiaga, MD, Private office, Serres, Greece
- Ledende efterforsker: Christos Babalis, MD, Private office, Serres, Greece
- Ledende efterforsker: Konstantinos Albantakis, MD, Private office, Larisa, Greece
- Ledende efterforsker: Martha Andritsou, MD, Sotiria Pulmonology Hospital of Athens
Publikationer og nyttige links
Generelle publikationer
- National Asthma Education and Prevention Program. National Asthma Education and Prevention Program. Expert Panel Report: Guidelines for the Diagnosis and Management of Asthma Update on Selected Topics--2002. J Allergy Clin Immunol. 2002 Nov;110(5 Suppl):S141-219. No abstract available. Erratum In: J Allergy Clin Immunol. 2003 Mar;111(3):466.
- van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.
- Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. doi: 10.1183/09031936.03.00097503.
- Perpina Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martinez Gonzalez del Rio J, Duce F, Munoz Cabrera L. [Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. Arch Bronconeumol. 2008 Jul;44(7):346-52. Spanish.
- van Beerendonk I, Mesters I, Mudde AN, Tan TD. Assessment of the inhalation technique in outpatients with asthma or chronic obstructive pulmonary disease using a metered-dose inhaler or dry powder device. J Asthma. 1998;35(3):273-9. doi: 10.3109/02770909809068218.
- Reliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients, accepted for publication by 'Archives of Hellenic Medicine'
- Global Strategy for Asthma Management and Prevention NIH Publication No 02-3659 Issued January, 1995 (updated 2002) Management Segment (Chapter 7): Updated 2005 from the 2004 document. The GINA reports are available on www.ginasthma.org
- British Thoracic Society; Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Thorax. 2003 Feb;58 Suppl 1(Suppl 1):i1-94. doi: 10.1136/thorax.58.suppl_1.1i. No abstract available.
- National Institutes of Health. Global strategy for asthma management and prevention. Bethesda (MD): Global Initiative for Asthma (GINA), National Institutes of Health, 2002 Feb. Publication no. 02-3659
- Dolovich MA, MacIntyre NR, Anderson PJ, Camargo CA Jr, Chew N, Cole CH, Dhand R, Fink JB, Gross NJ, Hess DR, Hickey AJ, Kim CS, Martonen TB, Pierson DJ, Rubin BK, Smaldone GC. Consensus statement: aerosols and delivery devices. American Association for Respiratory Care. Respir Care. 2000 Jun;45(6):589-96. No abstract available. Erratum In: Respir Care. 2000 Nov;45(11):1416.
- ICH topic E9 statistical principles for clinical trials - Note for guidance on statistical principles for clinical trials (CPMP/ICH/363/96).
- Frey U, Stocks J, Coates A, Sly P, Bates J. Specifications for equipment used for infant pulmonary function testing. ERS/ATS Task Force on Standards for Infant Respiratory Function Testing. European Respiratory Society/ American Thoracic Society. Eur Respir J. 2000 Oct;16(4):731-40. doi: 10.1034/j.1399-3003.2000.16d28.x.
- Lenney J, Innes JA, Crompton GK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med. 2000 May;94(5):496-500. doi: 10.1053/rmed.1999.0767.
- Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management and Prevention of Cronic Obstructive Pulmonary Disease (Updated 2009)
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-HAL-EL-32
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