Clinical trial NCT01455545: Impact of Adherence to Treatment in Asthma Control
Official title: Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire and Prescription Account.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Degree of Control
Exhaled Nitric Oxide
Asthma Control Test
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ASTHMA will be categorized into two subgroups: a) 50 patients with good asthma control according to the Asthma Control Test (ACT) score; b) 50 patients with bad control asthma according to the ACT score.

Brief summary: 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.

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) 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.

SECONDARY OBJECTIVES: a) analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and the fraction exhaled of nitric oxide (FeNO); b) analyze the relation between the level of asthma control according to the ACT score and the gender. c) analyze the relation between the level of asthma control according to the ACT score and smoking habit. d) analyze the correlation between the level of asthma control according to the ACT score and obesity. e) analyze the relation between the level of asthma control according to the ACT score and concomitant diseases (rhinitis, sinusitis or gastroesophageal reflux). f) analyze the relation between the level of asthma control according to the ACT score and concomitant psychiatric disorders. g) analyze the relation between the level of asthma control according to the ACT score and disease severity under the terms proposed by Global Initiative for Asthma (GINA).

METHOD: This is a observational cross-sectional study that includes a sample made up of 50 patients with good asthma control and 50 patients with poor asthma control according to the Asthma Control Test(ACT).

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, disease severity, rhinosinusitis, gastroesophageal reflux and concomitant psychiatric disorders and a standard physical examination. Measurement of asthma control with Asthma Control Test (ACT)will be performed. Then fraction exhaled of nitric oxide (FeNO)measurement and pulmonary function testing (forced spirometry and bronchodilator test) will be performed .

DEVICES AND MEASUREMENTS: Clinical variables will be collected in a case report form (CRF) specially developed for the study. Functional study: The spirometry will be performed according to the recommendations of European Respiratory Society using the Jaeger 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 flow and volume meter Lilly-type pneumotachograph . 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 criteria: Inclusion Criteria:

Patients with a diagnosis of asthma according to the Global Initiative for Asthma (GINA)guideline criteria .

Exclusion Criteria:

* Patients with a history of chronic obstructive pulmonary disease (COPD), residual pulmonary lesions or bronchiectasis seen on simple chest x-ray.
* Presence of another associated acute or chronic inflammatory disease.

Primary outcomes:
measure: Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.
timeFrame: 4 weeks
measure: Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.
timeFrame: 4 weeks
Secondary outcomes:
measure: Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Gender According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Smoking Habit According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Obesity According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Rhinitis According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Sinusitis According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Gastroesophageal Reflux According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Concomitant Psychiatric Disorders According to Level of Asthma Control.
timeFrame: 4 weeks
measure: Pulmonary Function Test (Spirometry) According to Level of Asthma Control.
timeFrame: 4 months
measure: Asthma Severity According to Level of Asthma Control.
timeFrame: 4 months
Other outcomes:
Locations:
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
state: Castilla la Mancha
Study officials:
affiliation: Sociedad Española de Neumología y Cirugía Torácica
name: Carlos Almonacid Sanchez, Phd, MD
role: PRINCIPAL_INVESTIGATOR
References: