Clinical trial NCT01800994: Prospective evAluatIon foR Inhalation Devices Study
Official title: Multicenter, Prospective, Observational, Non Interventional Clinical Trial to Assess the Asthma and COPD Treatment by Inhalation Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Keywords: convenience
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Asthma and COPD treated by inhalation devices

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: FSI-10 score
timeFrame: 2 months treatment
Secondary outcomes:
measure: Adverse Events Reporting
timeFrame: 2 months treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evagelismos hospital
city: Athens
country: Greece
facility: Private Office
city: Lamia
country: Greece
facility: General State hospital of Lamia
city: Piraeus
country: Greece
facility: Private Office
city: Volos
country: Greece
facility: Private Office
city: Voula
country: Greece
facility: Asklipiion Hospital
Study officials:
affiliation: Professor of Pulmonology, Attikon University Hospital of Athens
name: Spyridon Papiris, MD, Professor
role: STUDY_DIRECTOR
affiliation: Private Office
name: Athina Vlachou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Messini, Greece
name: Areti Xifteri-Nikolinati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Plmonology Hospital of Patras, Greece
name: Georgios Efraimidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Pyrgos, Peloponnese, Greece
name: Nikolaos Harokopos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Patras, Greece
name: Dionysia Kalampoka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Korinthos, Greece
name: Athanasia Christara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Chaidari, Athens, Greece
name: Emmanouel Fothiantakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonogy Hospital of Athens
name: Elias Kainis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonary Hospital of Athens
name: Adamantia Liapikou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Xenophon Agelidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thriasio General Hospital, Greece
name: Antonios Kopanakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Patisia, Athens, Greece
name: Konstantina Houliara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nea Filadelfia, Athens, Greece
name: Helen Adamou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Larissa, Greece
name: George Kalfountzos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Grevena, Greece
name: Athanasios Pitenis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Kaisariani, Athens, Greece
name: Eugeneia Karyanou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Gerakas, Attika, Greece
name: Georgia Kotantoula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Athens, Greece
name: Evangelos Bourantzis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonary Hospital of Athens
name: Konstantinos Marosis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonary Hospital of Athens
name: Harilaos Lambrakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonary Hospital of Athens
name: Anastasios Palamidas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Karditsa, Greece
name: Dimitrios Zois, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Rethymno, Crete, Greece
name: Maria Varouha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hatzikosta Hospital of Ioannina, Greece
name: Karmen Stahouli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Filiata, Thesprotia, Greece
name: Peter Oikonomides, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Thessaloniki, Greece
name: George Balasoulis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Thessaloniki, Greece
name: Konstantinos Porpodis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sismanogleio Hospital of Athens, Greece
name: Despina Melemeni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Greece
name: Andreas Stratis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon University Hospital of Athens, Greece
name: Efrosini Manali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Theageneio oncology hospital of Thessaloniki, Greece
name: Theodora Tsiounta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Papageorgiou hospital of Thessaloniki, Greece
name: Anna Gavriilidou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Papanikolaou General hospital of Thessaloniki, Greece
name: Athanasia Pataka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Kavala, Greece
name: Chrysavgi Terovitou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Kavala, Greece
name: Elisavet Christina Filippidou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Piraeus, Greece
name: Paschalis Kakavelas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Kalamaria, Thessaloniki, Greece
name: Nikolaos Manolakoglou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General hospital of Veroia, Greece
name: Evangelia Tsikrika, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Orestiada, Greece
name: Athanasios Papandreou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Kozani, Greece
name: Vasilios Adamidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Thessaloniki, Greece
name: Paraskevi Tsafaridou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Moudania, Thessaloniki, Greece
name: Maria Katertzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Serres, Greece
name: Pashalia Tsiaga, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Serres, Greece
name: Christos Babalis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Larisa, Greece
name: Konstantinos Albantakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotiria Pulmonology Hospital of Athens
name: Martha Andritsou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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'
citation: 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
citation: 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.
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citation: 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
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management and Prevention of Cronic Obstructive Pulmonary Disease (Updated 2009)