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Prospective evAluatIon foR Inhalation Devices Study (PAIR)

8 avril 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

750

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Athens, Grèce
        • Evagelismos hospital
      • Athens, Grèce
        • Private Office
      • Lamia, Grèce
        • General State hospital of Lamia
      • Piraeus, Grèce
        • Private Office
      • Volos, Grèce
        • Private Office
      • Voula, Grèce
        • Asklipiion Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with Asthma and COPD treated by inhalation devices

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
asthma, COPD
patients with asthma and COPD treated with inhalation devices

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
FSI-10 score
Délai: 2 months treatment
FSI-10 questionnaire total score FSI-10 questionnaire score per question
2 months treatment

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Adverse Events Reporting
Délai: 2 months treatment
Number of Adverse Events occured during study duration.
2 months treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 février 2013

Achèvement primaire (Réel)

1 décembre 2013

Achèvement de l'étude (Réel)

1 décembre 2013

Dates d'inscription aux études

Première soumission

20 février 2013

Première soumission répondant aux critères de contrôle qualité

26 février 2013

Première publication (Estimation)

28 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 avril 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 avril 2021

Dernière vérification

1 août 2014

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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