Prospective evAluatIon foR Inhalation Devices Study

NCT ID: NCT01800994

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Asthma; COPD

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

asthma, COPD

patients with asthma and COPD treated with inhalation devices

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elpen Pharmaceutical Co. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Spyridon Papiris, MD, Professor

Role: STUDY_DIRECTOR

Professor of Pulmonology, Attikon University Hospital of Athens

Athina Vlachou, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office

Areti Xifteri-Nikolinati, MD

Role: PRINCIPAL_INVESTIGATOR

Messini, Greece

Georgios Efraimidis, MD

Role: PRINCIPAL_INVESTIGATOR

Plmonology Hospital of Patras, Greece

Nikolaos Harokopos, MD

Role: PRINCIPAL_INVESTIGATOR

General hospital of Pyrgos, Peloponnese, Greece

Dionysia Kalampoka, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Patras, Greece

Athanasia Christara, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Korinthos, Greece

Emmanouel Fothiantakis, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Chaidari, Athens, Greece

Elias Kainis, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonogy Hospital of Athens

Adamantia Liapikou, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonary Hospital of Athens

Xenophon Agelidis, MD

Role: PRINCIPAL_INVESTIGATOR

Attikon Hospital

Antonios Kopanakis, MD

Role: PRINCIPAL_INVESTIGATOR

Thriasio General Hospital, Greece

Konstantina Houliara, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Patisia, Athens, Greece

Helen Adamou, MD

Role: PRINCIPAL_INVESTIGATOR

Nea Filadelfia, Athens, Greece

George Kalfountzos, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Larissa, Greece

Athanasios Pitenis, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Grevena, Greece

Eugeneia Karyanou, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Kaisariani, Athens, Greece

Georgia Kotantoula, MD

Role: PRINCIPAL_INVESTIGATOR

Private Office, Gerakas, Attika, Greece

Evangelos Bourantzis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Athens, Greece

Konstantinos Marosis, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonary Hospital of Athens

Harilaos Lambrakis, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonary Hospital of Athens

Anastasios Palamidas, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonary Hospital of Athens

Dimitrios Zois, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Karditsa, Greece

Maria Varouha, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Rethymno, Crete, Greece

Karmen Stahouli, MD

Role: PRINCIPAL_INVESTIGATOR

Hatzikosta Hospital of Ioannina, Greece

Peter Oikonomides, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Filiata, Thesprotia, Greece

George Balasoulis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Thessaloniki, Greece

Konstantinos Porpodis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Thessaloniki, Greece

Despina Melemeni, MD

Role: PRINCIPAL_INVESTIGATOR

Sismanogleio Hospital of Athens, Greece

Andreas Stratis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Greece

Efrosini Manali, MD

Role: PRINCIPAL_INVESTIGATOR

Attikon University Hospital of Athens, Greece

Theodora Tsiounta, MD

Role: PRINCIPAL_INVESTIGATOR

Theageneio oncology hospital of Thessaloniki, Greece

Anna Gavriilidou, MD

Role: PRINCIPAL_INVESTIGATOR

Papageorgiou hospital of Thessaloniki, Greece

Athanasia Pataka, MD

Role: PRINCIPAL_INVESTIGATOR

Papanikolaou General hospital of Thessaloniki, Greece

Chrysavgi Terovitou, MD

Role: PRINCIPAL_INVESTIGATOR

General hospital of Kavala, Greece

Elisavet Christina Filippidou, MD

Role: PRINCIPAL_INVESTIGATOR

General hospital of Kavala, Greece

Paschalis Kakavelas, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Piraeus, Greece

Nikolaos Manolakoglou, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Kalamaria, Thessaloniki, Greece

Evangelia Tsikrika, MD

Role: PRINCIPAL_INVESTIGATOR

General hospital of Veroia, Greece

Athanasios Papandreou, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Orestiada, Greece

Vasilios Adamidis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Kozani, Greece

Paraskevi Tsafaridou, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Thessaloniki, Greece

Maria Katertzi, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Moudania, Thessaloniki, Greece

Pashalia Tsiaga, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Serres, Greece

Christos Babalis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Serres, Greece

Konstantinos Albantakis, MD

Role: PRINCIPAL_INVESTIGATOR

Private office, Larisa, Greece

Martha Andritsou, MD

Role: PRINCIPAL_INVESTIGATOR

Sotiria Pulmonology Hospital of Athens

Locations

Evagelismos hospital

Athens, , Greece

Private Office

Athens, , Greece

General State hospital of Lamia

Lamia, , Greece

Private Office

Piraeus, , Greece

Private Office

Volos, , Greece

Asklipiion Hospital

Voula, , Greece

Countries

Greece

References

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'

Reference Type: BACKGROUND

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

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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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PMID: 12653493 (View on PubMed)

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.

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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

Reference Type: BACKGROUND

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.

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Reference Type: BACKGROUND

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.

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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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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.

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 10596686 (View on PubMed)

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.

Reference Type: BACKGROUND

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Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management and Prevention of Cronic Obstructive Pulmonary Disease (Updated 2009)

Reference Type: BACKGROUND

Other Identifiers

2012-HAL-EL-32

Identifier Type: -

Identifier Source: org_study_id