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Symptom-driven Maintenance and Reliever Treatment to Prevent Exacerbations in COPD

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ClinicalTrials.gov Identifier: NCT02477397
Recruitment Status : Unknown
Verified June 2015 by Maarten van den Berge, University Medical Center Groningen.
Recruitment status was:  Recruiting
First Posted : June 22, 2015
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Maarten van den Berge, University Medical Center Groningen

Brief Summary:
Study to investigate the effects of symptom-driven maintenance and reliever therapy in COPD.

Condition or disease Intervention/treatment Phase
COPD. Drug: Spiromax Budesonide/formoterol Drug: Diskus Fluticasone/salmeterol Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018


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.
Drug: 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.
Other Name: Spiromax® budesonide/formoterol

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.
Drug: 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.
Other Name: Diskus® Fluticasone/salmeterol




Primary Outcome Measures :
  1. Number of participants with increase in symptoms of dyspnea, cough, sputum production [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Lung function FEV1 [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Cell differential counts in blood [ Time Frame: 1 year ]
    Inflammation

  2. Symptoms Questionnaire (CCQ) [ Time Frame: 1 year ]
  3. Gene expression [ Time Frame: 1 year ]
    nasal gene expression signature



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477397


Contacts
Contact: Kai Imkamp, MD +31-50-3611743 k.imkamp@umcg.nl

Locations
Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713GZ
Contact: Maarten van den Berge, MD, PhD    +31-50-2615260    m.van.den.berge@umcg.nl   
Principal Investigator: Maarten van den Berge, MD, PhD         
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: Maarten van den Berge, MD, PhD University Medical Center Groningen

Responsible Party: Maarten van den Berge, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02477397     History of Changes
Other Study ID Numbers: SMART2014
First Posted: June 22, 2015    Key Record Dates
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by Maarten van den Berge, University Medical Center Groningen:
Spiromax
Budesonide/formoterol
COPD
exacerbations
SMART

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Fluticasone
Budesonide
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics