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

NCT00239499 | Completed Phase 4

• 1 other identifier: 205.273
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint will be FEV1 area under the curve for the time period 0 to 12 hours (FEV1 AUC0-12) measured after 6 weeks of treatment, at the final study visit (Visit 4).

Secondary Outcomes (1)

• Trough and peak FEV1. Trough FVC at Visits 3 and 4 and peak FVC and FVC AUC0-12 at Visit 4. Individual FEV1 and FVC measurements at each time point. Weekly mean number of puffs of rescue therapy used per day and night.

Interventions

Tiotropium DRUG

Salmeterol plus Fluticasone DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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®).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

Tijger Trial Centre

Bellville, 7530, South Africa

Location

Boehringer Ingelheim Investigational Site

Bloemfontein, 9301, South Africa

Location

UCT Lung Institute

Cape Town, 7700, South Africa

Location

Boehringer Ingelheim Investigational Site

Cape Town, 8001, South Africa

Location

Durban Lung Centre

Durban, 4001, South Africa

Location

St Augustine Hospital

Durban, 4001, South Africa

Location

QdotPharma

George, 6529, South Africa

Location

Centre for Chest Diseases Research Unit

Johannesburg, 2193, South Africa

Location

Boehringer Ingelheim Investigational Site

Paarl, 7646, South Africa

Location

Boehringer Ingelheim Investigational Site

Pretoria, 0001, South Africa

Location

Vergelegen Medi-Clinic

Somerset West, 7130, South Africa

Location

Boehringer Ingelheim Investigational Site

Welkom, 9460, South Africa

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. South Africa (Pty.) Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 17, 2005
• Study Start: September 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

ZA (12)