Prospective evAluatIon foR Inhalation Devices Study (P A I R)
|ClinicalTrials.gov Identifier: NCT01800994|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : August 19, 2014
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.
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.
|Condition or disease|
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.
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||750 participants|
|Official Title:||Multicenter, Prospective, Observational, Non Interventional Clinical Trial to Assess the Asthma and COPD Treatment by Inhalation Devices|
|Study Start Date :||February 2013|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
patients with asthma and COPD treated with inhalation devices
- FSI-10 score [ Time Frame: 2 months treatment ]FSI-10 questionnaire total score FSI-10 questionnaire score per question
- Adverse Events Reporting [ Time Frame: 2 months treatment ]Number of Adverse Events occured during study duration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800994
|Kallithea, Athens, Greece|
|General State hospital of Lamia|
|Study Director:||Spyridon Papiris, MD, Professor||Professor of Pulmonology, Attikon University Hospital of Athens|
|Principal Investigator:||Athina Vlachou, MD||Private Office|
|Principal Investigator:||Areti Xifteri-Nikolinati, MD||Messini, Greece|
|Principal Investigator:||Georgios Efraimidis, MD||Plmonology Hospital of Patras, Greece|
|Principal Investigator:||Nikolaos Harokopos, MD||General hospital of Pyrgos, Peloponnese, Greece|
|Principal Investigator:||Dionysia Kalampoka, MD||Private Office, Patras, Greece|
|Principal Investigator:||Athanasia Christara, MD||Private Office, Korinthos, Greece|
|Principal Investigator:||Emmanouel Fothiantakis, MD||Private Office, Chaidari, Athens, Greece|
|Principal Investigator:||Elias Kainis, MD||Sotiria Pulmonogy Hospital of Athens|
|Principal Investigator:||Adamantia Liapikou, MD||Sotiria Pulmonary Hospital of Athens|
|Principal Investigator:||Xenophon Agelidis, MD||Attikon University Hospital|
|Principal Investigator:||Antonios Kopanakis, MD||Thriasio General Hospital, Greece|
|Principal Investigator:||Konstantina Houliara, MD||Private office, Patisia, Athens, Greece|
|Principal Investigator:||Helen Adamou, MD||Nea Filadelfia, Athens, Greece|
|Principal Investigator:||George Kalfountzos, MD||Private office, Larissa, Greece|
|Principal Investigator:||Athanasios Pitenis, MD||Private Office, Grevena, Greece|
|Principal Investigator:||Eugeneia Karyanou, MD||Private Office, Kaisariani, Athens, Greece|
|Principal Investigator:||Georgia Kotantoula, MD||Private Office, Gerakas, Attika, Greece|
|Principal Investigator:||Evangelos Bourantzis, MD||Private office, Athens, Greece|
|Principal Investigator:||Konstantinos Marosis, MD||Sotiria Pulmonary Hospital of Athens|
|Principal Investigator:||Harilaos Lambrakis, MD||Sotiria Pulmonary Hospital of Athens|
|Principal Investigator:||Anastasios Palamidas, MD||Sotiria Pulmonary Hospital of Athens|
|Principal Investigator:||Dimitrios Zois, MD||General Hospital of Karditsa, Greece|
|Principal Investigator:||Maria Varouha, MD||Private office, Rethymno, Crete, Greece|
|Principal Investigator:||Karmen Stahouli, MD||Hatzikosta Hospital of Ioannina, Greece|
|Principal Investigator:||Peter Oikonomides, MD||General Hospital of Filiata, Thesprotia, Greece|
|Principal Investigator:||George Balasoulis, MD||Private office, Thessaloniki, Greece|
|Principal Investigator:||Konstantinos Porpodis, MD||Private office, Thessaloniki, Greece|
|Principal Investigator:||Despina Melemeni, MD||Sismanogleio Hospital of Athens, Greece|
|Principal Investigator:||Andreas Stratis, MD||Private office, Greece|
|Principal Investigator:||Efrosini Manali, MD||Attikon University Hospital of Athens, Greece|
|Principal Investigator:||Theodora Tsiounta, MD||Theageneio oncology hospital of Thessaloniki, Greece|
|Principal Investigator:||Anna Gavriilidou, MD||Papageorgiou hospital of Thessaloniki, Greece|
|Principal Investigator:||Athanasia Pataka, MD||Papanikolaou General hospital of Thessaloniki, Greece|
|Principal Investigator:||Chrysavgi Terovitou, MD||General hospital of Kavala, Greece|
|Principal Investigator:||Elisavet Christina Filippidou, MD||General hospital of Kavala, Greece|
|Principal Investigator:||Paschalis Kakavelas, MD||Private office, Piraeus, Greece|
|Principal Investigator:||Nikolaos Manolakoglou, MD||Private office, Kalamaria, Thessaloniki, Greece|
|Principal Investigator:||Evangelia Tsikrika, MD||General hospital of Veroia, Greece|
|Principal Investigator:||Athanasios Papandreou, MD||Private office, Orestiada, Greece|
|Principal Investigator:||Vasilios Adamidis, MD||Private office, Kozani, Greece|
|Principal Investigator:||Paraskevi Tsafaridou, MD||Private office, Thessaloniki, Greece|
|Principal Investigator:||Maria Katertzi, MD||Private office, Moudania, Thessaloniki, Greece|
|Principal Investigator:||Pashalia Tsiaga, MD||Private office, Serres, Greece|
|Principal Investigator:||Christos Babalis, MD||Private office, Serres, Greece|
|Principal Investigator:||Konstantinos Albantakis, MD||Private office, Larisa, Greece|
|Principal Investigator:||Martha Andritsou, MD||Sotiria Pulmonology Hospital of Athens|