NCT02477397

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 22, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

4.1 years

First QC Date

May 28, 2015

Last Update Submit

July 8, 2019

Conditions

COPD

Keywords

SpiromaxBudesonide/formoterolCOPDexacerbationsSMART

Outcome Measures

Primary Outcomes (1)

  • Number of participants with increase in symptoms of dyspnea, cough, sputum production

    1 year

Secondary Outcomes (1)

  • Lung function FEV1

    1 year

Other Outcomes (3)

  • Cell differential counts in blood

    1 year

  • Symptoms Questionnaire (CCQ)

    1 year

  • Gene expression

    1 year

Study Arms (2)

Spiromax Budesonide/formoterol

EXPERIMENTAL

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

Diskus Fluticasone/salmeterol

ACTIVE COMPARATOR

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

Interventions

Spiromax Budesonide/formoterolDRUG

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.

Also known as: Spiromax® budesonide/formoterol
Spiromax Budesonide/formoterol
Diskus Fluticasone/salmeterolDRUG

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.

Also known as: Diskus® Fluticasone/salmeterol
Diskus Fluticasone/salmeterol

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Related Publications (1)

  • Wisselink HJ, Pelgrim GJ, Rook M, Dudurych I, van den Berge M, de Bock GH, Vliegenthart R. Improved precision of noise estimation in CT with a volume-based approach. Eur Radiol Exp. 2021 Sep 10;5(1):39. doi: 10.1186/s41747-021-00237-x.

    PMID: 34505172DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol FumarateSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesAlbuterolPhenethylaminesEthylamines

Study Officials

  • Maarten van den Berge, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 22, 2015

Study Start

May 1, 2015

Primary Completion

June 15, 2019

Study Completion

December 15, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

NL(1)