This research proposal aims to investigate the efficacy of the SMART approach with budesonide/fomoterol versus fixed dose treatment with fluticasone/salmeterol in patients with COPD.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the reduction in number of exacerbations (moderately
severe ad severe exacerbation combined).
Secondary outcome
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.
Background summary
Chronic obstructive pulmonary disease (COPD) is a leading cause of death
worldwide and its morbidity and mortality are still rising. A symptom-driven
maintenance and reliever therapy (SMART) with budesonide/formoterol is a
frequently used treatment strategy in asthma. Several studies have shown that
the SMART approach effectively reduces the number of asthma exacerbations when
compared to a fixed maintenance dose of, e.g. fluticasone/salmeterol. In
addition, larger improvements in lung function and symptoms have been observed
in asthma patients with the SMART approach. Thus far, no studies have
investigated the efficacy of the SMART approach in patients with COPD. We
hypothesize that SMART treatment with budesonide/formoterol will be more
effective than fluticasone/salmeterol fixed dose treatment in COPD.
Study objective
This research proposal aims to investigate the efficacy of the SMART approach
with budesonide/fomoterol versus fixed dose treatment with
fluticasone/salmeterol in patients with COPD.
Study design
This will be a randomized, parallel 2-arm, open-label, multi-centre study.
Intervention
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 160/4.5 *g as needed with a maximum of
8 inhalations daily.
B: One year Diskus® fluticasone/salmeterol 500/50 *g one inhalation twice daily
+ salbutamol 100 *g as needed with a maximum of 8 inhalations daily.
Study burden and risks
This study has no specific benefits for the participating patients. The study
also has no major risks.
Minor risks for participant in this study are:
* Nasal epithelium collection may cause a temporary nose bleed.
* Blood collection may cause bruising.
* All drugs may cause side effects. For further information about the side
effects of Spiromax® budesonide/formoterol see page 29 of this protocol. For
further information about the side effects of Diskus® fluticasone/salmeterol
see page 42 of this protocol.
* Temporary quitting of anti-inflammatory inhalation medication may cause
worsening of the symptoms resulting in an exacerbation.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
* 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001563-12-NL |
| CCMO | NL48953.042.14 |