Prospective evAluatIon foR Inhalation Devices Study (PAIR)

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.

Study Overview

• Status: Completed
• Conditions: Asthma; COPD

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.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Evagelismos hospital
  • Athens, Greece
    • Private office
  • Lamia, Greece
    • General State hospital of Lamia
  • Piraeus, Greece
    • Private office
  • Volos, Greece
    • Private office
  • Voula, Greece
    • Asklipiion Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Asthma and COPD treated by inhalation devices

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
asthma, COPD; patients with asthma and COPD treated with inhalation devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FSI-10 score	FSI-10 questionnaire total score FSI-10 questionnaire score per question	2 months treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Reporting	Number of Adverse Events occured during study duration.	2 months treatment

Collaborators and Investigators

• Sponsor: Elpen Pharmaceutical Co. Inc.
• Investigators: Study Director: Spyridon Papiris, MD, Professor, Professor of Pulmonology, Attikon University Hospital of Athens; Principal Investigator: 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

Publications and helpful links

General Publications

• 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. Erratum In: J Allergy Clin Immunol. 2003 Mar;111(3):466.
• 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.
• 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.
• 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.
• 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.
• 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'
• 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
• 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.
• 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
• 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. Erratum In: Respir Care. 2000 Nov;45(11):1416.
• ICH topic E9 statistical principles for clinical trials - Note for guidance on statistical principles for clinical trials (CPMP/ICH/363/96).
• 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.
• 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.
• Global Initiative for Chronic Obstructive Lung Disease, Global Strategy for the Diagnosis, Management and Prevention of Cronic Obstructive Pulmonary Disease (Updated 2009)

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: convenience
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2012-HAL-EL-32