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Completed

NCT Number: NCT00996697

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group, Ninewells Hospital and Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide/formoterol and tiotropium

Drug

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

Budesonide/formoterol and placebo

Drug

Symbicort 200/6 2puff bid and placebo

Primary outcomes

  1. Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination

    Time frame: 2 weeks

Secondary outcomes

  1. Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination

    Time frame: 2 weeks

  2. Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Brian J Lipworth

Other

Registry information

Official study title

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

Acronym: FARD12

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 16, 2009
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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