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

• Status: Unknown status
• Trial end date: 2019-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate; Xhance

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.