Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD.
Intervention: Spiromax Budesonide/formoterol (Drug); Diskus Fluticasone/salmeterol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Maarten van den Berge, MD, PhD, Principal Investigator, Affiliation: University Medical Center Groningen
Overall contact: Kai Imkamp, MD, Phone: +31-50-3611743, Email: k.imkamp@umcg.nl
Summary
Study to investigate the effects of symptom-driven maintenance and reliever therapy in COPD.
Clinical Details
Official title: Effectiveness of Single Inhaler Maintenance and Reliever Therapy With Spiromax® Budesonide/Formoterol (SMART) Versus Fixed Dose Treatment With Diskus® Fluticasone/Salmeterol in Patients With a Chronic Obstructive Pulmonary Disease (COPD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with increase in symptoms of dyspnea, cough, sputum production
Secondary outcome: Lung function FEV1
Detailed description:
Rationale: 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. The investigators
hypothesize that SMART treatment with budesonide/formoterol will be more effective than
fluticasone/salmeterol fixed dose treatment in COPD.
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.
Study population: A total of 260 COPD patients will be included with a smoking history of
>10 pack years, an FEV1 <80% predicted either or not using inhaled corticosteroids and
having had at least one COPD exacerbation during the 2 years prior to inclusion.
Intervention: COPD patients will be randomized to one of the following two treatment groups:
A: One year Spiromax® budesonide/formoterol 160/4. 5 μg two inhalations twice daily +
Spiromax® budesonide/formoterol 160/4. 5 μg as needed with a maximum of 8 inhalations daily.
B: One year Diskus® fluticasone/salmeterol 500/50 μg one inhalation twice daily + salbutamol
100 μg as needed with a maximum of 8 inhalations daily.
Main study endpoints/objectives: The primary endpoint is the reduction in number of COPD
exacerbations requiring treatment with oral prednisolone).
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: This study has no specific benefits for the participating patients. The study
also has no major risks. Minor risks for participants in this study are:
- Nasal epithelium collection may cause a temporary nose bleed.
- Blood collection may cause bruising.
- All drugs may cause side effects. The combination treatments with an inhaled
corticosteroid and long-acting β2-agonist: budesonide/formoterol and
fluticasone/salmeterol are medicinal products that have been on the market for many
years in many countries and they are often prescribed both in asthma and COPD.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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:
- 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:
1. Surgical sterilization (e. g. bilateral tubal ligation, hysterectomy).
2. Hormonal contraception (implantable, patch, oral, injectable).
3. Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/cream/suppository.
4. 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.
Locations and Contacts
Kai Imkamp, MD, Phone: +31-50-3611743, Email: k.imkamp@umcg.nl
University Medical Center Groningen, Groningen 9713GZ, Netherlands; Recruiting Maarten van den Berge, MD, PhD, Phone: +31-50-2615260, Email: m.van.den.berge@umcg.nl Maarten van den Berge, MD, PhD, Principal Investigator
Additional Information
Starting date: May 2015
Last updated: June 19, 2015
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