Prospective evAluatIon foR Inhalation Devices Study (P A I R)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01800994
First received: February 20, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition
Asthma
COPD

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multicenter, Prospective, Observational, Non Interventional Clinical Trial to Assess the Asthma and COPD Treatment by Inhalation Devices

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • FSI-10 score [ Time Frame: 2 months treatment ] [ Designated as safety issue: Yes ]
    FSI-10 questionnaire total score FSI-10 questionnaire score per question


Secondary Outcome Measures:
  • Adverse Events Reporting [ Time Frame: 2 months treatment ] [ Designated as safety issue: Yes ]
    Number of Adverse Events occured during study duration.


Enrollment: 750
Study Start Date: February 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
asthma, COPD
patients with asthma and COPD treated with inhalation devices

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Asthma and COPD treated by inhalation devices

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01800994

Locations
Greece
Evagelismos hospital
Athens, Greece
Private Office
Kallithea, Athens, Greece
General State hospital of Lamia
Lamia, Greece
Private Office
Piraeus, Greece
Private Office
Volos, Greece
Asklipiion Hospital
Voula, Greece
Sponsors and Collaborators
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 University 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
  More Information

Publications:

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01800994     History of Changes
Other Study ID Numbers: 2012-HAL-EL-32
Study First Received: February 20, 2013
Last Updated: August 18, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
convenience

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014