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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Athens, Grecia
- Evagelismos hospital
-
Athens, Grecia
- Private office
-
Lamia, Grecia
- General State hospital of Lamia
-
Piraeus, Grecia
- Private office
-
Volos, Grecia
- Private office
-
Voula, Grecia
- Asklipiion Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
asthma, COPD
patients with asthma and COPD treated with inhalation devices
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
FSI-10 score
Periodo de tiempo: 2 months treatment
|
FSI-10 questionnaire total score FSI-10 questionnaire score per question
|
2 months treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse Events Reporting
Periodo de tiempo: 2 months treatment
|
Number of Adverse Events occured during study duration.
|
2 months treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Spyridon Papiris, MD, Professor, Professor of Pulmonology, Attikon University Hospital of Athens
- Investigador principal: Athina Vlachou, MD, Private office
- Investigador principal: Areti Xifteri-Nikolinati, MD, Messini, Greece
- Investigador principal: Georgios Efraimidis, MD, Plmonology Hospital of Patras, Greece
- Investigador principal: Nikolaos Harokopos, MD, General hospital of Pyrgos, Peloponnese, Greece
- Investigador principal: Dionysia Kalampoka, MD, Private Office, Patras, Greece
- Investigador principal: Athanasia Christara, MD, Private Office, Korinthos, Greece
- Investigador principal: Emmanouel Fothiantakis, MD, Private Office, Chaidari, Athens, Greece
- Investigador principal: Elias Kainis, MD, Sotiria Pulmonogy Hospital of Athens
- Investigador principal: Adamantia Liapikou, MD, Sotiria Pulmonary Hospital of Athens
- Investigador principal: Xenophon Agelidis, MD, Attikon Hospital
- Investigador principal: Antonios Kopanakis, MD, Thriasio General Hospital, Greece
- Investigador principal: Konstantina Houliara, MD, Private office, Patisia, Athens, Greece
- Investigador principal: Helen Adamou, MD, Nea Filadelfia, Athens, Greece
- Investigador principal: George Kalfountzos, MD, Private office, Larissa, Greece
- Investigador principal: Athanasios Pitenis, MD, Private Office, Grevena, Greece
- Investigador principal: Eugeneia Karyanou, MD, Private Office, Kaisariani, Athens, Greece
- Investigador principal: Georgia Kotantoula, MD, Private Office, Gerakas, Attika, Greece
- Investigador principal: Evangelos Bourantzis, MD, Private office, Athens, Greece
- Investigador principal: Konstantinos Marosis, MD, Sotiria Pulmonary Hospital of Athens
- Investigador principal: Harilaos Lambrakis, MD, Sotiria Pulmonary Hospital of Athens
- Investigador principal: Anastasios Palamidas, MD, Sotiria Pulmonary Hospital of Athens
- Investigador principal: Dimitrios Zois, MD, General Hospital of Karditsa, Greece
- Investigador principal: Maria Varouha, MD, Private office, Rethymno, Crete, Greece
- Investigador principal: Karmen Stahouli, MD, Hatzikosta Hospital of Ioannina, Greece
- Investigador principal: Peter Oikonomides, MD, General Hospital of Filiata, Thesprotia, Greece
- Investigador principal: George Balasoulis, MD, Private office, Thessaloniki, Greece
- Investigador principal: Konstantinos Porpodis, MD, Private office, Thessaloniki, Greece
- Investigador principal: Despina Melemeni, MD, Sismanogleio Hospital of Athens, Greece
- Investigador principal: Andreas Stratis, MD, Private office, Greece
- Investigador principal: Efrosini Manali, MD, Attikon University Hospital of Athens, Greece
- Investigador principal: Theodora Tsiounta, MD, Theageneio oncology hospital of Thessaloniki, Greece
- Investigador principal: Anna Gavriilidou, MD, Papageorgiou hospital of Thessaloniki, Greece
- Investigador principal: Athanasia Pataka, MD, Papanikolaou General hospital of Thessaloniki, Greece
- Investigador principal: Chrysavgi Terovitou, MD, General hospital of Kavala, Greece
- Investigador principal: Elisavet Christina Filippidou, MD, General hospital of Kavala, Greece
- Investigador principal: Paschalis Kakavelas, MD, Private office, Piraeus, Greece
- Investigador principal: Nikolaos Manolakoglou, MD, Private office, Kalamaria, Thessaloniki, Greece
- Investigador principal: Evangelia Tsikrika, MD, General hospital of Veroia, Greece
- Investigador principal: Athanasios Papandreou, MD, Private office, Orestiada, Greece
- Investigador principal: Vasilios Adamidis, MD, Private office, Kozani, Greece
- Investigador principal: Paraskevi Tsafaridou, MD, Private office, Thessaloniki, Greece
- Investigador principal: Maria Katertzi, MD, Private office, Moudania, Thessaloniki, Greece
- Investigador principal: Pashalia Tsiaga, MD, Private office, Serres, Greece
- Investigador principal: Christos Babalis, MD, Private office, Serres, Greece
- Investigador principal: Konstantinos Albantakis, MD, Private office, Larisa, Greece
- Investigador principal: Martha Andritsou, MD, Sotiria Pulmonology Hospital of Athens
Publicaciones y enlaces útiles
Publicaciones Generales
- 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)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012-HAL-EL-32
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .