Impact of Adherence to Treatment in Asthma Control

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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: June 4, 2013
Last verified: June 2013

October 10, 2011
June 4, 2013
January 2011
February 2012   (final data collection date for primary outcome measure)
  • Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.

    Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.

    To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers).

  • Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19.

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.
Complete list of historical versions of study NCT01455545 on ClinicalTrials.gov Archive Site
  • Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).

    Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19.

  • Gender According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.

    Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.

  • Smoking Habit According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.

    Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked.

  • Obesity According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.

    Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 .

  • Rhinitis According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.

    Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.

    Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline.

  • Sinusitis According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

    Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group.

  • Gastroesophageal Reflux According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.

    Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

  • Concomitant Psychiatric Disorders According to Level of Asthma Control. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.

    Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

  • Pulmonary Function Test (Spirometry) According to Level of Asthma Control. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).

    Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

  • Asthma Severity According to Level of Asthma Control. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

    Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).

    Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.

  • 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 ]
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Impact of Adherence to Treatment in Asthma Control
Impact of Adherence to Treatment in Asthma Control Using ASK-20 Questionnaire and Prescription Account.

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.

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.

Observational
Time Perspective: Cross-Sectional
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Non-Probability Sample

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.

Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
14 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01455545
HUGU ASMA 001
Yes
CARLOS ALMONACID SANCHEZ, Sociedad Española de Neumología y Cirugía Torácica
Sociedad Española de Neumología y Cirugía Torácica
Merck Sharp & Dohme Corp.
Principal Investigator: Carlos Almonacid Sanchez, Phd, MD Sociedad Española de Neumología y Cirugía Torácica
Sociedad Española de Neumología y Cirugía Torácica
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP