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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996697

Acronym

FARD12

Enrollment

Registered

2009-10-16

Start date

2006-10-31

Completion date

2008-09-30

Last updated

2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD (chronic obstructive pulmonary disease)

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.

Interventions

DRUGBudesonide/formoterol and tiotropium

Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day

DRUGBudesonide/formoterol and placebo

Symbicort 200/6 2puff bid and placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026