- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00996697
Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD) (FARD12)
April 10, 2019 updated by: Brian J Lipworth
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tayside
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Dundee, Tayside, United Kingdom, DD1 9SY
- Asthma and Allergy Research Group, Ninewells Hospital and Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Triple therapy
Symbicort and tiotropium
|
Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day
|
PLACEBO_COMPARATOR: Combination therapy
Symbicort and placebo
|
Symbicort 200/6 2puff bid and placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination
Time Frame: 2 weeks
|
2 weeks
|
Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (ACTUAL)
September 1, 2008
Study Completion (ACTUAL)
September 1, 2008
Study Registration Dates
First Submitted
October 15, 2009
First Submitted That Met QC Criteria
October 15, 2009
First Posted (ESTIMATE)
October 16, 2009
Study Record Updates
Last Update Posted (ACTUAL)
April 12, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Tiotropium Bromide
- Formoterol Fumarate
- Budesonide, Formoterol Fumarate Drug Combination
Other Study ID Numbers
- FARD12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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