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

NCT00996697 | Completed Phase 4

• 1 other identifier: FARD12
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Keywords

COPD (chronic obstructive pulmonary disease)

Outcome Measures

Primary Outcomes (1)

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

  2 weeks

Secondary Outcomes (2)

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

  2 weeks

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

  4 weeks

Study Arms (2)

Triple therapy

ACTIVE COMPARATOR

Symbicort and tiotropium

Drug: Budesonide/formoterol and tiotropium

Combination therapy

PLACEBO COMPARATOR

Symbicort and placebo

Drug: Budesonide/formoterol and placebo

Interventions

Budesonide/formoterol and tiotropium DRUG

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

Triple therapy

Budesonide/formoterol and placebo DRUG

Symbicort 200/6 2puff bid and placebo

Combination therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian J Lipworth: lead

Study Sites (1)

Asthma and Allergy Research Group, Ninewells Hospital and Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20418370 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Formoterol Fumarate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor (Clinical) Airway allergy and COPD

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)