Efficacy of Symptom-driven treatment with inhaled budesonide/formoterol versus fixed dose fluticasone/salmeterol in COPD

• Conditions: Chronic obstructive pulmonary disease (COPD); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001563-12-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 18 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified