- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01599871
Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease (ASSET)
Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
The main objective of the study is to determine the effects of low-dose oral theophylline added to combination treatment with long-acting β-agonist (LABA) and inhaled corticosteroid (ICS) in patients with severe Chronic Obstructive Pulmonary Disease (COPD) on the rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
DESIGN: Phase III multicenter, randomized, placebo-controlled, double blind, parallel, prospective study. Patient will be recruited during an hospitalisation due to COPD exacerbation and randomised at the time of discharge to receive theophylline 100 mg or placebo on top of combination therapy with inhaled corticosteroids and long-acting beta agonist. The rate of exacerbations will be determined every three months up to one year follow-up. Cl inic visits: every 3 months (total number of clinic visits = 4). In each of them, the following information will be obtained:
- Number/severity of exacerbations or hospitalisation since last clinic visit
- Compliance and side effects
- Blood sample
- Plasma levels of theophylline
- Sputum (induced)
- MMRC
- SGRQ
Forced spirometry + inspiratory capacity
- At the beginning and at the end of the study
- 6MWT
- BMI
- BODE
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08003
- Hospital del Mar
-
Barcelona, Spain, 08025
- Hospital de Sant Pau
-
Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Madrid, Spain, 28009
- Hospital Gregorio Marañón
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Madrid, Spain, 28040
- Fundacion Jimenez Diaz
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Madrid, Spain, 28044
- Hospital 12 de Octubre
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Zaragoza, Spain, 50004
- Hospital Miguel Servet
-
-
Baleares
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Palma de Mallorca, Baleares, Spain, 07010
- Hospital Universitario Son Espases
-
-
Islas Canarias
-
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
- Hospital Universitario Nuestra Senora de la Candelaria
-
-
Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Ability to understand study procedures and to comply with them for the entire length of the study.
- Any gender. No contraception is required neither pregnancy expected in the range of age
- Age > 45 years
- Smoking history > 10 pack-years (current or ex-smokers)
- Clinical diagnosis of COPD
- Presence of severe airflow obstruction on forced spirometry (FEV1/FVC < 0.7 and post-BD FEV1 < 50% of reference value) staged as GOLD III or IV
- Diagnosis of COPD exacerbation on discharge.
Exclusion Criteria:
- Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
- Cancer
- Heart failure
- Pregnancy, or risk of pregnancy
- Other inflammatory diseases
- Previous treatment with theophylline
- For drug studies: allergy/sensitivity to study drugs or their ingredients.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
|
theophylline 100 mg, twice at day
|
Placebo Comparator: Control
inhaled corticosteroids and long-acting beta agonist + Placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of exacerbations
Time Frame: 1 year
|
Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of hospitalisation
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Borja G Cosio, MD, Hospital Son Espases
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Theophylline
Other Study ID Numbers
- 1559-F-447
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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