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Prospective evAluatIon foR Inhalation Devices Study (PAIR)

8 aprile 2021 aggiornato da: Elpen Pharmaceutical Co. Inc.

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

750

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Patients with Asthma and COPD treated by inhalation devices

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
asthma, COPD
patients with asthma and COPD treated with inhalation devices

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
FSI-10 score
Lasso di tempo: 2 months treatment
FSI-10 questionnaire total score FSI-10 questionnaire score per question
2 months treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse Events Reporting
Lasso di tempo: 2 months treatment
Number of Adverse Events occured during study duration.
2 months treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Spyridon Papiris, MD, Professor, Professor of Pulmonology, Attikon University Hospital of Athens
  • Investigatore principale: Athina Vlachou, MD, Private Office
  • Investigatore principale: Areti Xifteri-Nikolinati, MD, Messini, Greece
  • Investigatore principale: Georgios Efraimidis, MD, Plmonology Hospital of Patras, Greece
  • Investigatore principale: Nikolaos Harokopos, MD, General hospital of Pyrgos, Peloponnese, Greece
  • Investigatore principale: Dionysia Kalampoka, MD, Private Office, Patras, Greece
  • Investigatore principale: Athanasia Christara, MD, Private Office, Korinthos, Greece
  • Investigatore principale: Emmanouel Fothiantakis, MD, Private Office, Chaidari, Athens, Greece
  • Investigatore principale: Elias Kainis, MD, Sotiria Pulmonogy Hospital of Athens
  • Investigatore principale: Adamantia Liapikou, MD, Sotiria Pulmonary Hospital of Athens
  • Investigatore principale: Xenophon Agelidis, MD, Attikon Hospital
  • Investigatore principale: Antonios Kopanakis, MD, Thriasio General Hospital, Greece
  • Investigatore principale: Konstantina Houliara, MD, Private office, Patisia, Athens, Greece
  • Investigatore principale: Helen Adamou, MD, Nea Filadelfia, Athens, Greece
  • Investigatore principale: George Kalfountzos, MD, Private office, Larissa, Greece
  • Investigatore principale: Athanasios Pitenis, MD, Private Office, Grevena, Greece
  • Investigatore principale: Eugeneia Karyanou, MD, Private Office, Kaisariani, Athens, Greece
  • Investigatore principale: Georgia Kotantoula, MD, Private Office, Gerakas, Attika, Greece
  • Investigatore principale: Evangelos Bourantzis, MD, Private office, Athens, Greece
  • Investigatore principale: Konstantinos Marosis, MD, Sotiria Pulmonary Hospital of Athens
  • Investigatore principale: Harilaos Lambrakis, MD, Sotiria Pulmonary Hospital of Athens
  • Investigatore principale: Anastasios Palamidas, MD, Sotiria Pulmonary Hospital of Athens
  • Investigatore principale: Dimitrios Zois, MD, General Hospital of Karditsa, Greece
  • Investigatore principale: Maria Varouha, MD, Private office, Rethymno, Crete, Greece
  • Investigatore principale: Karmen Stahouli, MD, Hatzikosta Hospital of Ioannina, Greece
  • Investigatore principale: Peter Oikonomides, MD, General Hospital of Filiata, Thesprotia, Greece
  • Investigatore principale: George Balasoulis, MD, Private office, Thessaloniki, Greece
  • Investigatore principale: Konstantinos Porpodis, MD, Private office, Thessaloniki, Greece
  • Investigatore principale: Despina Melemeni, MD, Sismanogleio Hospital of Athens, Greece
  • Investigatore principale: Andreas Stratis, MD, Private office, Greece
  • Investigatore principale: Efrosini Manali, MD, Attikon University Hospital of Athens, Greece
  • Investigatore principale: Theodora Tsiounta, MD, Theageneio oncology hospital of Thessaloniki, Greece
  • Investigatore principale: Anna Gavriilidou, MD, Papageorgiou hospital of Thessaloniki, Greece
  • Investigatore principale: Athanasia Pataka, MD, Papanikolaou General hospital of Thessaloniki, Greece
  • Investigatore principale: Chrysavgi Terovitou, MD, General hospital of Kavala, Greece
  • Investigatore principale: Elisavet Christina Filippidou, MD, General hospital of Kavala, Greece
  • Investigatore principale: Paschalis Kakavelas, MD, Private office, Piraeus, Greece
  • Investigatore principale: Nikolaos Manolakoglou, MD, Private office, Kalamaria, Thessaloniki, Greece
  • Investigatore principale: Evangelia Tsikrika, MD, General hospital of Veroia, Greece
  • Investigatore principale: Athanasios Papandreou, MD, Private office, Orestiada, Greece
  • Investigatore principale: Vasilios Adamidis, MD, Private office, Kozani, Greece
  • Investigatore principale: Paraskevi Tsafaridou, MD, Private office, Thessaloniki, Greece
  • Investigatore principale: Maria Katertzi, MD, Private office, Moudania, Thessaloniki, Greece
  • Investigatore principale: Pashalia Tsiaga, MD, Private office, Serres, Greece
  • Investigatore principale: Christos Babalis, MD, Private office, Serres, Greece
  • Investigatore principale: Konstantinos Albantakis, MD, Private office, Larisa, Greece
  • Investigatore principale: Martha Andritsou, MD, Sotiria Pulmonology Hospital of Athens

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2013

Completamento primario (Effettivo)

1 dicembre 2013

Completamento dello studio (Effettivo)

1 dicembre 2013

Date di iscrizione allo studio

Primo inviato

20 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

26 febbraio 2013

Primo Inserito (Stima)

28 febbraio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 aprile 2021

Ultimo verificato

1 agosto 2014

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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