Impact of Adherence to Treatment in Asthma Control

This study is currently recruiting participants.
Verified October 2011 by Sociedad Española de Neumología y Cirugía Torácica
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01455545
First received: October 10, 2011
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

This survey aims to analyze how adherence to treatment using Ask-20 questionnaire and prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire According to the Severity of the Disease.

Resource links provided by NLM:


Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • Analyze how adherence to treatment using ASK-20 questionnaire and prescription account influences level of asthma control in a sample of patients with severe and moderate-mild asthma. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To analyze how adherence to treatment using ASK-20 questionnaire and prescription account influences level of asthma control in a sample of patients with severe and moderate-mild asthma.


Secondary Outcome Measures:
  • Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ) scores and the fraction exhaled of nitric oxide (FeNO) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and the gender [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and smoking habit [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and obesity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and concomitant psychiatric disorders [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Analyze the most relevant differences in the study population [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Detailed Description:

Duration of illness, poor adherence to treatment, gender, smoking habit, obesity, concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux) and concomitant psychiatric disorders may be responsible for an increase and perpetuation of the inflammatory response as well as a decreased response to treatment and may be easily identified clinically.

PRIMARY OBJECTIVES: a) To analyze how adherence to treatment influences level of asthma control in a sample of patients with severe and moderate-mild asthma.

SECONDARY OBJECTIVES: a) To analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) and the Asthma Control Questionnaire (ACQ) scores and the fraction exhaled of nitric oxide (FeNO); b) To analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and the gender. c) To analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and smoking habit. d) To analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and obesity. e) To analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux). f) To analyze the correlation between the level of asthma control according to the ACT and the ACQ scores and concomitant psychiatric disorders. g) To analyze the most relevant differences in the study population.

METHOD: This is a observational cross-sectional study that includes a sample made up of 50 patients with severe asthma and 50 patients with mild-moderate asthma according to the Global Initiative for Asthma (GINA).

DEVELOPMENT OF THE STUDY After signing the informed consent, data will be collected including gender, smoking habit, alcohol consumption, environmental and employment factors, weight, height, body mass index (BMI), history of atopy, rhinosinusitis, gastroesophageal reflux and concomitant psychiatric disorders and a standard physical examination. Measurement of asthma control with the ACQ and ACT questionnaires will be performed. Then FeNO measurement and pulmonary function testing (forced spirometry and bronchodilator test) will be performed .

DEVICES AND MEASUREMENTS: Clinical variables will be collected in a CRF(case report form) specially developed for the study. Functional study: The spirometry will be performed according to the recommendations of European Respiratory Society using the Jaëger Master Lab system.

Bronchodilator test will be performed with albuterol and ipratropium bromide inhalation solution. FeNO levels will be measured of using the Filt's Vario analyzer which allows for bronchial or nasal tests, with a Lilly-type pnemo-tacographic flow and volume meter. Adherence to treatment will be assessed with the ASK-20 questionnaire and reviewing the number of prescriptions for asthma during the last 6 months.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with severe asthma according to the GINA 2009 criteria; 50) patients with mild-moderate asthma.

Criteria

Inclusion Criteria:

  • Patient group with severe asthma - group A (n = 50): meet the GINA 2009 diagnostic criteria for severe asthma
  • Patient group with mild-moderate asthma - group B (n = 50): meet the GINA 2009 diagnostic criteria for mild-moderate asthma .

Exclusion Criteria:

  • Patients with a history of COPD, residual pulmonary lesions or bronchiectasis seen on simple chest x-ray.
  • Presence of another associated acute or chronic inflammatory disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455545

Contacts
Contact: Carlos Almonacid Sanchez, PhD, MD +34 655534475 caralmsan@yahoo.es

Locations
Spain
Hospital Universitario de Guadalajara Recruiting
Guadalajara, Castilla la Mancha, Spain, 19002
Contact: Carlos Almonacid Sanchez, PhD, MD     +34 655 53 44 75     caralmsan@yahoo.es    
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Merck
Investigators
Principal Investigator: Carlos Almonacid Sanchez, Phd, MD Sociedad Española de Neumología y Cirugía Torácica
  More Information

No publications provided

Responsible Party: CARLOS ALMONACID SANCHEZ, PhD, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01455545     History of Changes
Other Study ID Numbers: HUGU ASMA 001
Study First Received: October 10, 2011
Last Updated: October 18, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
Asthma
Degree of Control
Exhaled Nitric Oxide
Asthma Control Test

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 May 23, 2013