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CompletedNCT00996697FARD12Updated Apr 12, 2019

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

A Phase 4 interventional study of Budesonide/formoterol and tiotropium and Budesonide/formoterol and placebo in COPD, sponsored by Brian J Lipworth. Completed at 1 site in United Kingdom. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-04-12.

Sponsored by Brian J Lipworth · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • COPD

Keywords

  • COPD (chronic obstructive pulmonary disease)
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In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 23 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Brian J Lipworth is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    Triple therapy

    Symbicort and tiotropium

    Drug: Budesonide/formoterol and tiotropium

  • Placebo comparator
    Combination therapy

    Symbicort and placebo

    Drug: Budesonide/formoterol and placebo

Interventions

  • DrugBudesonide/formoterol and tiotropium

    Drug pages: Budesonide · Formoterol · Tiotropium

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

  • DrugBudesonide/formoterol and placebo

    Symbicort 200/6 2puff bid and placebo

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What researchers measure

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

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Study locations

1 site
  • Asthma and Allergy Research Group, Ninewells Hospital and Medical School
    Dundee, Tayside DD1 9SY, United Kingdom
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References and documents

Publications

  • 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. PubMed 20418370 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006, a primary completion of Sep 2008 and a completion of Sep 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2009
First posted
Oct 16, 2009
Start
Oct 2006
Primary completionActual
Sep 2008
CompletionActual
Sep 2008
Last update
Apr 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00996697
Lead sponsor
Brian J Lipworth
Responsible party
Brian J Lipworth (Professor (Clinical) Airway allergy and COPD, University of Dundee) — Sponsor-investigator
First posted
Oct 16, 2009
Start date
Oct 2006
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Apr 12, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Budesonide · Formoterol · Tiotropium

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