Clinical trial NCT00996697: Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Proof Of Concept Study To Evaluate Tiotropium as Add-on Therapy to Inhaled Budesonide/Formoterol Combination in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: COPD (chronic obstructive pulmonary disease)
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination
timeFrame: 2 weeks
measure: Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, Ninewells Hospital and Medical School
state: Tayside
Study officials:
References:
citation: 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. doi: 10.1378/chest.10-0247. Epub 2010 Apr 23.