COPDPhase 4FARD12NCT00996697
Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Budesonide/formoterol and tiotropium in people with COPD, run by Brian J Lipworth at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Budesonide/formoterol and tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or ex-smokers
- aged over 50years
- FEV1/FVC ratio less than 0.7
- FEV1 less than 60% predicted
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Tayside, DD1 9SY
About this study
Official title: A Proof Of Concept Study To Evaluate Tiotropium as Add-on Therapy to Inhaled Budesonide/Formoterol Combination in 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.
- Conditions
- COPD
- Being tested
- Budesonide/formoterol and tiotropium, Budesonide/formoterol and placebo
- Keywords
- COPD (chronic obstructive pulmonary disease)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterol and tiotropiumDrug
Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day
Budesonide/formoterol and placeboDrug
Symbicort 200/6 2puff bid and placebo
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy | Active comparator | Symbicort and tiotropium Receives: Drug: Budesonide/formoterol and tiotropium |
| Combination therapy | Placebo comparator | Symbicort and placebo Receives: Drug: Budesonide/formoterol and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination
Measured: 2 weeks
Secondary outcomes (2)
Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination
Measured: 2 weeks
Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian J Lipworth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian J Lipworth, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996697
- Sponsor's protocol ID
- FARD12
- Acronym
- FARD12
- Status last verified
- Apr 2019
- First submitted
- 15 Oct 2009
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof Of Concept Study To Evaluate Tiotropium as Add-on Therapy to Inhaled Budesonide/Formoterol Combination in COPD
- ClinicalTrials.gov ID
- NCT00996697
- Acronym / sponsor ID
- FARD12 / FARD12
- Conditions
- COPD
- Keywords
- COPD (chronic obstructive pulmonary disease)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brian J LipworthUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy | Active comparator | Drug: Budesonide/formoterol and tiotropiumSymbicort and tiotropium |
| Combination therapy | Placebo comparator | Drug: Budesonide/formoterol and placeboSymbicort and placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current or ex-smokers
- aged over 50years
- FEV1/FVC ratio less than 0.7
- FEV1 less than 60% predicted
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/formoterol and tiotropiumSymbicort 200/2, 2puff bid plus tiotropium 18mcg/day | Drug | Triple therapy |
| Budesonide/formoterol and placeboSymbicort 200/6 2puff bid and placebo | Drug | Combination therapy |
Primary outcome
Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination
Time frame: 2 weeks
2 secondary outcomes
Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination
Time frame: 2 weeks
Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Results publication: PubMed 20418370Williamson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/formoterol and tiotropium in people with COPD, run by Brian J Lipworth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.