Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease (ASSET)
This study is currently recruiting participants.
Verified May 2012 by Hospital Son Espases
Sponsor:
Hospital Son Espases
Collaborators:
Spanish Research Center for Respiratory Diseases
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Borja Cosio, Hospital Son Espases
ClinicalTrials.gov Identifier:
NCT01599871
First received: May 14, 2012
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: theophylline Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD |
Resource links provided by NLM:
Further study details as provided by Hospital Son Espases:
Primary Outcome Measures:
- Rate of exacerbations [ Time Frame: 1 year ] [ Designated as safety issue: No ]Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
Secondary Outcome Measures:
- Number of hospitalisation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 128 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.)
|
Drug: theophylline
theophylline 100 mg, twice at day
|
|
Placebo Comparator: Control
inhaled corticosteroids and long-acting beta agonist + Placebo
|
Other: placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 45 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599871
Contacts
| Contact: Borja G Cosio, MD | +34 871205050 | borja.cosio@ssib.es |
Locations
| Spain | |
| Hospital Universitario Son Espases | Recruiting |
| Palma de Mallorca, Baleares, Spain, 07010 | |
| Contact +34871205050 borja.cosio@ssib.es | |
| Hospital Universitario Nuestra Señora de la Candelaria | Not yet recruiting |
| Santa Cruz de Tenerife, Islas Canarias, Spain, 38010 | |
| Clínica Universitaria de Navarra | Not yet recruiting |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital de Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain, 08003 | |
| Hospital Clínic de Barcelona | Recruiting |
| Barcelona, Spain, 08036 | |
| Hospital 12 de Octubre | Not yet recruiting |
| Madrid, Spain, 28044 | |
| Fundación Jiménez Díaz | Recruiting |
| Madrid, Spain, 28040 | |
| Hospital Gregorio Marañón | Not yet recruiting |
| Madrid, Spain, 28009 | |
| Hospital Miguel Servet | Not yet recruiting |
| Zaragoza, Spain, 50004 | |
Sponsors and Collaborators
Hospital Son Espases
Spanish Research Center for Respiratory Diseases
Fundación Mutua Madrileña
Investigators
| Principal Investigator: | Borja G Cosio, MD | Hospital Universitario Son Espases |
More Information
No publications provided
| Responsible Party: | Borja Cosio, MD, PhD, Hospital Son Espases |
| ClinicalTrials.gov Identifier: | NCT01599871 History of Changes |
| Other Study ID Numbers: | 1559-F-447 |
| Study First Received: | May 14, 2012 |
| Last Updated: | May 15, 2012 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Son Espases:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Theophylline Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013