SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Bromides; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

Inclusion criteria:

• Established clinical history of moderate to severe COPD.

• Post bronchodilator FEV1 of < 50% of predicted normal.

• FEV1 / FVC ratio <70%.

• Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.

• Free from exacerbation in the 6 weeks prior to screening.

• Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria:

• Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.

• Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).

• Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.

• Has undergone lung transplantation and/or lung volume reduction.

• Female who is a nursing mother.

• Requires regular (daily) long-term oxygen therapy (LTOT).

• Is receiving beta-blockers (except eye drops).

• Has a serious, uncontrolled disease likely to interfere with the study.

• Has received any other investigational drugs within the 4 weeks prior to Visit 1.

• Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.

• Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).