Chronic obstructive pulmonary disease COPD
Conditions
Interventions
COPD patients will be randomized to one of the following two treatment groups:
A: One year Spiromax® budesonide/formoterol 160/4.5 *g two inhalations twice
daily + Spiromax® budesonide/formoterol 16
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * 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.
Exclusion criteria
Exclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the reduction in number of exacerbations (moderately severe ad severe exacerbation combined). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: * Lung function (PEF, FEV1, FEV1/FVC, FVC, FEF25-75%, RV, TLC, RV/TLC, RV/TLC %predicted); * IOS measurements, R5, R20, R5-R20, X5, AX; * Questionnaires (inhaler device satisfaction [PASAPQ and FSI-10], side effects [ICQ], health status [CCQ and SGRQ] and CAT); * Change of the lung microbiome in induced sputum (in a subset of patients); * Moderately severe and severe exacerbations analyzed separately; * Analysis of baseline clinical and targeted as well as genome-wide gene-expression data to identify predictors for a favorable ICS treatment response in COPD. | — |
Countries
Netherlands
Outcome results
None listed