Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)

Phase 4

Completed

• Conditions: COPD
• Interventions: Drug: Budesonide/formoterol and tiotropium; Drug: Budesonide/formoterol and placebo

• Registration Number: NCT00996697
• Lead Sponsor: Brian J Lipworth

Brief Summary

Different medications are often used in combination for the condition COPD (chronic obstructive pulmonary disease). Some medicines act by opening the airways (bronchodilators) and some act as anti-inflammatories (steroids). More recently an approach of using a combination inhaler (containing a steroid and a long-acting bronchodilator) at the same time as a long acting bronchodilator of a different group of medicines (anti-cholinergics inhalers) has been used. This approach is sometimes called 'triple therapy'. Studies which have looked at these combinations usually use only standard blowing tests (spirometry) to test these medicines and focus on the effects of the medicines at their highest (peak) levels. It is some ways more relevant to study these medicines towards to end of the dose period (trough)- just before the next dose. This is when there is less medicine in the system, and differences in drug effects are more obvious. There are also more detailed breathing tests than spirometry which get a more detailed picture of the way the lungs respond to bronchodilator medicines. The investigators have studied 'triple therapy' in COPD, by measuring the effects at the end of the dosing interval (trough) using a range of detailed respiratory tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Current or ex-smokers
• aged over 50years
• FEV1/FVC ratio less than 0.7
• FEV1 less than 60% predicted

Exclusion Criteria

• Diagnosis of asthma, ABPA or bronchiectasis
• Recent RTI or steroid use
• Inability to perform study procedures or to give informed consent
• Known sensitivity to trial medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Triple therapy	Budesonide/formoterol and tiotropium	Symbicort and tiotropium
Combination therapy	Budesonide/formoterol and placebo	Symbicort and placebo

Primary Outcome Measures

Name	Time	Method
Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination	2 weeks

Secondary Outcome Measures

Name	Time	Method
Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination	2 weeks
Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline	4 weeks

Trial Locations

Locations (1)

Asthma and Allergy Research Group, Ninewells Hospital and Medical School; 🇬🇧 Dundee, Tayside, United Kingdom