Differential Trough Effects of 'Triple Therapy' on Pulmonary Function in Chronic Obstructive Pulmonary Disease (COPD) (FARD12)

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00996697
First received: October 15, 2009
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
COPD
Drug: Budesonide/formoterol and tiotropium
Drug: Budesonide/formoterol and placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Proof Of Concept Study To Evaluate Tiotropium as Add-on Therapy to Inhaled Budesonide/Formoterol Combination in COPD

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Change in trough FEV1 for tiotropium compared to placebo when added to formoterol/budesonide combination [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in IOS and bodyplethysmography at trough for tiotropium compared to placebo when added to formoterol/budesonide combination [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Change in spirometry, IOS and Bodyplethysmography at trough for formoterol/budesonide compared to washed-out baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triple therapy
Symbicort and tiotropium
Drug: Budesonide/formoterol and tiotropium
Symbicort 200/2, 2puff bid plus tiotropium 18mcg/day
Placebo Comparator: Combination therapy
Symbicort and placebo
Drug: Budesonide/formoterol and placebo
Symbicort 200/6 2puff bid and placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996697

Locations
United Kingdom
Asthma and Allergy Research Group, Ninewells Hospital and Medical School
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
  More Information

Additional Information:
No publications provided

Responsible Party: Peter A Williamson, University of Dundee
ClinicalTrials.gov Identifier: NCT00996697     History of Changes
Other Study ID Numbers: FARD12
Study First Received: October 15, 2009
Last Updated: October 16, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University of Dundee:
COPD (chronic obstructive pulmonary disease)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol
Tiotropium
Budesonide
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 01, 2014