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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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-
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Athens, Řecko
- Evagelismos hospital
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Athens, Řecko
- Private office
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Lamia, Řecko
- General State hospital of Lamia
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Piraeus, Řecko
- Private office
-
Volos, Řecko
- Private office
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Voula, Řecko
- Asklipiion Hospital
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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asthma, COPD
patients with asthma and COPD treated with inhalation devices
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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FSI-10 score
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adverse Events Reporting
Časové okno: 2 months treatment
|
Number of Adverse Events occured during study duration.
|
2 months treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Spyridon Papiris, MD, Professor, Professor of Pulmonology, Attikon University Hospital of Athens
- Vrchní vyšetřovatel: Athina Vlachou, MD, Private office
- Vrchní vyšetřovatel: Areti Xifteri-Nikolinati, MD, Messini, Greece
- Vrchní vyšetřovatel: Georgios Efraimidis, MD, Plmonology Hospital of Patras, Greece
- Vrchní vyšetřovatel: Nikolaos Harokopos, MD, General hospital of Pyrgos, Peloponnese, Greece
- Vrchní vyšetřovatel: Dionysia Kalampoka, MD, Private Office, Patras, Greece
- Vrchní vyšetřovatel: Athanasia Christara, MD, Private Office, Korinthos, Greece
- Vrchní vyšetřovatel: Emmanouel Fothiantakis, MD, Private Office, Chaidari, Athens, Greece
- Vrchní vyšetřovatel: Elias Kainis, MD, Sotiria Pulmonogy Hospital of Athens
- Vrchní vyšetřovatel: Adamantia Liapikou, MD, Sotiria Pulmonary Hospital of Athens
- Vrchní vyšetřovatel: Xenophon Agelidis, MD, Attikon Hospital
- Vrchní vyšetřovatel: Antonios Kopanakis, MD, Thriasio General Hospital, Greece
- Vrchní vyšetřovatel: Konstantina Houliara, MD, Private office, Patisia, Athens, Greece
- Vrchní vyšetřovatel: Helen Adamou, MD, Nea Filadelfia, Athens, Greece
- Vrchní vyšetřovatel: George Kalfountzos, MD, Private office, Larissa, Greece
- Vrchní vyšetřovatel: Athanasios Pitenis, MD, Private Office, Grevena, Greece
- Vrchní vyšetřovatel: Eugeneia Karyanou, MD, Private Office, Kaisariani, Athens, Greece
- Vrchní vyšetřovatel: Georgia Kotantoula, MD, Private Office, Gerakas, Attika, Greece
- Vrchní vyšetřovatel: Evangelos Bourantzis, MD, Private office, Athens, Greece
- Vrchní vyšetřovatel: Konstantinos Marosis, MD, Sotiria Pulmonary Hospital of Athens
- Vrchní vyšetřovatel: Harilaos Lambrakis, MD, Sotiria Pulmonary Hospital of Athens
- Vrchní vyšetřovatel: Anastasios Palamidas, MD, Sotiria Pulmonary Hospital of Athens
- Vrchní vyšetřovatel: Dimitrios Zois, MD, General Hospital of Karditsa, Greece
- Vrchní vyšetřovatel: Maria Varouha, MD, Private office, Rethymno, Crete, Greece
- Vrchní vyšetřovatel: Karmen Stahouli, MD, Hatzikosta Hospital of Ioannina, Greece
- Vrchní vyšetřovatel: Peter Oikonomides, MD, General Hospital of Filiata, Thesprotia, Greece
- Vrchní vyšetřovatel: George Balasoulis, MD, Private office, Thessaloniki, Greece
- Vrchní vyšetřovatel: Konstantinos Porpodis, MD, Private office, Thessaloniki, Greece
- Vrchní vyšetřovatel: Despina Melemeni, MD, Sismanogleio Hospital of Athens, Greece
- Vrchní vyšetřovatel: Andreas Stratis, MD, Private office, Greece
- Vrchní vyšetřovatel: Efrosini Manali, MD, Attikon University Hospital of Athens, Greece
- Vrchní vyšetřovatel: Theodora Tsiounta, MD, Theageneio oncology hospital of Thessaloniki, Greece
- Vrchní vyšetřovatel: Anna Gavriilidou, MD, Papageorgiou hospital of Thessaloniki, Greece
- Vrchní vyšetřovatel: Athanasia Pataka, MD, Papanikolaou General hospital of Thessaloniki, Greece
- Vrchní vyšetřovatel: Chrysavgi Terovitou, MD, General hospital of Kavala, Greece
- Vrchní vyšetřovatel: Elisavet Christina Filippidou, MD, General hospital of Kavala, Greece
- Vrchní vyšetřovatel: Paschalis Kakavelas, MD, Private office, Piraeus, Greece
- Vrchní vyšetřovatel: Nikolaos Manolakoglou, MD, Private office, Kalamaria, Thessaloniki, Greece
- Vrchní vyšetřovatel: Evangelia Tsikrika, MD, General hospital of Veroia, Greece
- Vrchní vyšetřovatel: Athanasios Papandreou, MD, Private office, Orestiada, Greece
- Vrchní vyšetřovatel: Vasilios Adamidis, MD, Private office, Kozani, Greece
- Vrchní vyšetřovatel: Paraskevi Tsafaridou, MD, Private office, Thessaloniki, Greece
- Vrchní vyšetřovatel: Maria Katertzi, MD, Private office, Moudania, Thessaloniki, Greece
- Vrchní vyšetřovatel: Pashalia Tsiaga, MD, Private office, Serres, Greece
- Vrchní vyšetřovatel: Christos Babalis, MD, Private office, Serres, Greece
- Vrchní vyšetřovatel: Konstantinos Albantakis, MD, Private office, Larisa, Greece
- Vrchní vyšetřovatel: Martha Andritsou, MD, Sotiria Pulmonology Hospital of Athens
Publikace a užitečné odkazy
Obecné publikace
- 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)
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2012-HAL-EL-32
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