Prospective evAluatIon foR Inhalation Devices Study

NCT01800994 | Completed

• 1 other identifier: 2012-HAL-EL-32
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma; COPD

Keywords

convenience

Outcome Measures

Primary Outcomes (1)

• FSI-10 score

  FSI-10 questionnaire total score FSI-10 questionnaire score per question

  2 months treatment

Secondary Outcomes (1)

• Adverse Events Reporting

  2 months treatment

Study Arms (1)

asthma, COPD

patients with asthma and COPD treated with inhalation devices

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Asthma and COPD treated by inhalation devices

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (6)

Evagelismos hospital

Athens, Greece

Location

Private Office

Athens, Greece

Location

General State hospital of Lamia

Lamia, Greece

Location

Private Office

Piraeus, Greece

Location

Private Office

Volos, Greece

Location

Asklipiion Hospital

Voula, Greece

Location

Related Publications (14)

• 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'

  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

  BACKGROUND

• 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.

  PMID: 12653493 BACKGROUND

• 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.

  PMID: 12542074 BACKGROUND

• 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

  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.

  PMID: 10894452 BACKGROUND

• ICH topic E9 statistical principles for clinical trials - Note for guidance on statistical principles for clinical trials (CPMP/ICH/363/96).

  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.

  PMID: 11106221 BACKGROUND

• 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.

  PMID: 9661680 BACKGROUND

• 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.

  PMID: 12882462 BACKGROUND

• 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.

  PMID: 10868714 BACKGROUND

• 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.

  PMID: 10596686 BACKGROUND

• 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.

  PMID: 18727886 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Spyridon Papiris, MD, Professor

  Professor of Pulmonology, Attikon University Hospital of Athens

  STUDY DIRECTOR

• 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 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 28, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 12, 2021

Record last verified: 2014-08

Locations

GR (6)