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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
Results First Received: August 17, 2012  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Condition: Asthma

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment: Jan 2011 to Jan 2012. Location: medical clinic. Sampling method: Non-Probability Sample. Ages Eligible for Study: 16 yars to 80 years. Genders Eligible for Study: both.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bad Control Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
Good Control Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.

Participant Flow:   Overall Study
    Bad Control     Good Control  
STARTED     55     45  
COMPLETED     55     45  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Asthmatic Patients

Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.

In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA).


Baseline Measures
    Asthmatic Patients  
Number of Participants  
[units: participants]
  100  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     87  
>=65 years     10  
Age  
[units: years]
Mean ± Standard Deviation
  45.25  ± 15.89  
Gender  
[units: participants]
 
Female     66  
Male     34  
Region of Enrollment  
[units: participants]
 
Spain     100  



  Outcome Measures
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1.  Primary:   Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.   [ Time Frame: 4 weeks ]

2.  Primary:   Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.   [ Time Frame: 4 weeks ]

3.  Secondary:   Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

4.  Secondary:   Gender According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

5.  Secondary:   Smoking Habit According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

6.  Secondary:   Obesity According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

7.  Secondary:   Rhinitis According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

8.  Secondary:   Sinusitis According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

9.  Secondary:   Gastroesophageal Reflux According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

10.  Secondary:   Concomitant Psychiatric Disorders According to Level of Asthma Control.   [ Time Frame: 4 weeks ]

11.  Secondary:   Pulmonary Function Test (Spirometry) According to Level of Asthma Control.   [ Time Frame: 4 months ]

12.  Secondary:   Asthma Severity According to Level of Asthma Control.   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is an observational (cross-sectional )study, with the limitations and biases associated. Patients have not been randomized.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Carlos Almonacid
Organization: SESCAM - HOSPITAL UNIVERSITARIO DE GUADALAJARA
phone: +34 655 53 44 75
e-mail: caralmsan@gmail.com


No publications provided


Responsible Party: CARLOS ALMONACID SANCHEZ, 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
Results First Received: August 17, 2012
Last Updated: June 4, 2013
Health Authority: Spain: Ethics Committee