Pilot Study Comparing Tiotropium (Spiriva) to Salmeterol (Serevent) Plus Fluticasone (Flixotide) in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to estimate the comparative bronchodilator effect size and variability for tiotropium (Spiriva, 18 µg q.d.) with the free combination of salmeterol (Serevent, 50 µg b.i.d.) and fluticasone (Flixotide, 250 µg b.i.d.) in COPD patients.

International COPD guidelines preserve milder stages of the disease (GOLD stage I and IIa) to bronchodilators and recommend the addition of inhaled corticosteroids only in those patients who have a documented spirometric response to inhaled corticosteroids and in patients with a post-bronchodilator FEV1 of less than 50% predicted, who suffer from frequent exacerbations requiring oral courses of corticosteroids.

Recently published reports indicate that additional bronchodilator efficacy may be achieved when a long-acting beta agonist is combined with an inhaled corticosteroid. Steady state bronchodilation was achieved within one week with the drug combination. However, results of these studies are not consistent, and since the inclusion criteria employed were different from those utilised in the previously conducted tiotropium studies, it is difficult to generalise the observed effects to the general COPD population.

In addition, no comparative data is available on the average response over the 12 daytime hours when COPD patients are active and in most need of bronchodilation. 12 hours corresponds to the dosing intervals for both salmeterol and fluticasone.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide

Criteria

Inclusion criteria:

• All patients must have a diagnosis of chronic obstructive pulmonary disease according to the GOLD criteria and must meet the following spirometric criteria:

• Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 < 80% of predicted normal and FEV1/FVC < 70% at Visit 1, and a pre-dose FEV1 < 65% predicted at Visit 2.

• Male or female patients 40 years of age or older. There is no upper age limit.

• Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.

Exclusion criteria:

• Patients with significant diseases other than COPD.

• Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count more than or equal to 600/mm3.

• Patients who have been treated with commercially available tiotropium (Spiriva®).