Compliance During Long-Term Treatment with Fluticasone Propionate in Subjects with Early Signs of Asthma or Chronic Obstructive Pulmonary Disease (COPD): Results of the Detection, Intervention, and Monitoring Program of COPD and Asthma (DIMCA) Study

In a prospective study, we investigated the long-term compliance to fluticasone propionate (FP) by dry powder inhalation (Rotadisk®) in subjects with early signs of asthma and chronic obstructive pulmonary disease (COPD) without an established diagnosis. Subjects were selected from a large screening program on early stages of asthma and COPD (Detection, Intervention, and Monitoring Program of COPD and Asthma [DIMCA] program) in the general practice. Forty-eight adult subjects with “early signs of COPD” (slightly increased forced expiratory volume in 1 sec [FEV1] decline of >0.04L/year) and 29 adult subjects with “early signs of asthma” (signs of bronchial hyperresponsiveness or reversibility) participated in a randomized placebo-controlled trial with FP (Flixotide® 500 jag daily) versus placebo with a duration of 2 years or 1 year, respectively. Compliance was measured by counting Rotadisks returned. By means of a questionnaire, participants were asked about perceived effects and/or side effects of the trial drug. The mean overall individual compliance rates of 72% (range 7%-102%) in the early COPD trial and 71% (range 8%-99%) in the early asthma trial were maintained throughout the study. Perceived effectiveness (12% of the participants) or side effects (30% of the participants) of the trial drug were not related to compliance. The willingness of patients to use the trial drug in daily practice if efficacy would be proved was statistically significantly related to compliance during the trial (p = 0.017). It was concluded that the compliance rates found were relatively high in patients with symptoms of mild asthma or COPD without an established diagnosis. Conviction of the importance of treatment influenced compliance more positively than perceived (side) effects. These results again emphasize the importance of patient education in establishing early treatment with inhaled corticosteroids.

[1]  S Griffith,et al.  A review of the factors associated with patient compliance and the taking of prescribed medicines. , 1990, The British journal of general practice : the journal of the Royal College of General Practitioners.

[2]  J. Sbarbaro.  The patient-physician relationship: compliance revisited. , 1990, Annals of allergy.

[3]  C. van Weel,et al.  Treatment with inhaled steroids in asthma and chronic bronchitis: long-term compliance and inhaler technique. , 1992, Family practice.

[4]  R. Clark,et al.  An Assessment of the Acceptability of Two Breath-Actuated Corticosteroid Inhalers Comparison of Turbohaler® with Diskhaler® , 1990 .

[5]  D. Parry,et al.  Patient compliance with inhaled medication: does combining beta-agonists with corticosteroids improve compliance? , 1994, The European respiratory journal.

[6]  M. Cowles,et al.  Long-term metered-dose inhaler adherence in a clinical trial. The Lung Health Study Research Group. , 1995, American journal of respiratory and critical care medicine.

[7]  Joyce A. Cramer,et al.  Patient Compliance in Medical Practice and Clinical Trials , 1991 .

[8]  J. Sunyer,et al.  Immunopathology of fatal soybean dust-induced asthma. , 1996, The European respiratory journal.

[9]  C. Rand,et al.  Measuring adherence to asthma medication regimens. , 1994, American journal of respiratory and critical care medicine.

[10]  C. van Weel,et al.  Active detection of chronic obstructive pulmonary disease and asthma in the general population. Results and economic consequences of the DIMCA program. , 1998, American journal of respiratory and critical care medicine.

[11]  I. Bernstein.  Report of the American Academy of Allergy and Immunology Task Force on Guidelines for Clinical Investigation of Nonbronchodilator Antiasthmatic Drugs. , 1986, The Journal of allergy and clinical immunology.

[12]  C. Smith.  Achieving Patient Compliance: The Psychology of the Medical Practitioner's Role , 1983 .

[13]  C. van Weel,et al.  The role of "fear of corticosteroids" in nonparticipation in early intervention with inhaled corticosteroids in asthma and COPD in general practice. , 1998, The European respiratory journal.

[14]  J. Boe,et al.  Is long-term treatment with inhaled steroids in adults hazardous? , 1992, The European respiratory journal.

[15]  R. Bone,et al.  Goals of asthma management. A step-care approach. , 1996, Chest.

[16]  C. Rand,et al.  Metered-dose inhaler adherence in a clinical trial. , 1992, The American review of respiratory disease.

[17]  B. Zimmerman,et al.  Patient compliance. Are we wasting our time and don't know it? , 1992, The American review of respiratory disease.

[18]  C. Rand,et al.  Trends in compliance with bronchodilator inhaler use between follow-up visits in a clinical trial. , 1996, Chest.

[19]  C. Weel,et al.  The effectiveness of inhaled steroids as first-line therapy in the treatment of newly detected asthma in the open population , 1996 .

[20]  D. Tashkin.  Multiple dose regimens. Impact on compliance. , 1995, Chest.

[21]  C. Weel,et al.  Active Detection of Chronic Obstructive Pulmonary Disease and Asthma in the General Population Results and Economic Consequences of the DIMCA Program GUIDO van den BOOM, CONSTANT P. van SCHAYCK, MAUREEN P. M. H. RUTTEN-van MÖLKEN, , 1998 .