Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD
- Conditions
- Chronic obstructive pulmonary diseaseCOPD10006436
- Registration Number
- NL-OMON44539
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 260
* Age between 40 and 80 years
* Smoking history of > 10 pack years
* COPD patients with an FEV1 < 80% predicted either or not using inhaled corticosteroids.
* At least one COPD exacerbation for which oral prednisolone had to be prescribed during 2 years prior to inclusion in the study.
* History of asthma.
* Exacerbation or respiratory tract infection during the last 4 weeks prior to randomization.
* Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
b) Hormonal contraception (implantable, patch, oral, injectable).
c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
d) Continuous abstinence.
* Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the reduction in number of exacerbations (moderately<br /><br>severe ad severe exacerbation combined). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>* Lung function (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%, RV, TLC, RV/TLC, RV/TLC<br /><br>%predicted);<br /><br>* IOS measurements, R5, R20, R5-R20, X5, AX;<br /><br>* Questionnaires (inhaler device satisfaction [PASAPQ and FSI-10], side effects<br /><br>[ICQ], health status [CCQ and SGRQ] and CAT);<br /><br>* Change of the lung microbiome in induced sputum (in a subset of patients);<br /><br>* Moderately severe and severe exacerbations analyzed separately;<br /><br>* Analysis of baseline clinical and targeted as well as genome-wide<br /><br>gene-expression data to identify predictors for a favorable ICS treatment<br /><br>response in COPD. </p><br>