- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02477397
Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Groningen, Netherlands, 9713GZ
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
- Hormonal contraception (implantable, patch, oral, injectable).
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spiromax Budesonide/formoterol
1.
In Group A, Patients will be treated with 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 additional inhalations daily.
|
1.
In Group A, Patients will be treated with 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 additional inhalations daily.
Other Names:
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Active Comparator: Diskus Fluticasone/salmeterol
2. In group B, Patients will be treated with Diskus® fluticasone/salmeterol 500/50 μg one inhalation twice daily + salbutamol 100 μg as needed with a maximum of 8 inhalations daily.
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2. In group B, Patients will be treated with Diskus® fluticasone/salmeterol 500/50 μg one inhalation twice daily + salbutamol 100 μg as needed with a maximum of 8 inhalations daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with increase in symptoms of dyspnea, cough, sputum production
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lung function FEV1
Time Frame: 1 year
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cell differential counts in blood
Time Frame: 1 year
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Inflammation
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1 year
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Symptoms Questionnaire (CCQ)
Time Frame: 1 year
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1 year
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Gene expression
Time Frame: 1 year
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nasal gene expression signature
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Maarten van den Berge, MD, PhD, University Medical Center Groningen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Budesonide
- Fluticasone
- Xhance
- Salmeterol Xinafoate
- Fluticasone-Salmeterol Drug Combination
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- SMART2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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