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

COPD Clinical Trial

— FARD12  

Official title:

A Proof Of Concept Study To Evaluate Tiotropium as Add-on Therapy to Inhaled Budesonide/Formoterol Combination in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996697
• Other study ID #: FARD12
• Status: Completed
• Phase: Phase 4
• Start date: October 2006
• Est. completion date: September 2008

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide/formoterol and tiotropium
Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day
• Budesonide/formoterol and placebo
Symbicort 200/6 2puff bid and placebo

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, Ninewells Hospital and Medical School	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
Brian J Lipworth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Williamson PA, Short PM, Clearie KL, Vaidyanathan S, Fardon TC, Howaniec LJ, Lipworth BJ. Paradoxical trough effects of triple therapy with budesonide/formoterol and tiotropium bromide on pulmonary function outcomes in COPD. Chest. 2010 Sep;138(3):595-604 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination		2 weeks
Secondary	Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination		2 weeks
Secondary	Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline		4 weeks