Chronic Obstructive Pulmonary DiseasePhase 3ASSETNCT01599871
Low-dose Theophylline as Anti-inflammatory Enhancer in Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing theophylline in people with Chronic Obstructive Pulmonary Disease, run by Hospital Son Espases at 10 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- theophylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 10 sitesSpain
- Study dates
- Jan 2011to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital del Mar
Barcelona, 08003
Hospital de Sant Pau
Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Gregorio Marañón
Madrid, 28009
Fundación Jiménez Díaz
Madrid, 28040
Hospital 12 de Octubre
Madrid, 28044
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Miguel Servet
Zaragoza, 50004
About this study
Official title: 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- theophylline, placebo
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
theophyllineDrug
theophylline 100 mg, twice at day
placeboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Inhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.) Receives: Drug: theophylline |
| Control | Placebo comparator | inhaled corticosteroids and long-acting beta agonist + Placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of exacerbations
Rate of exacerbations defined as increase of symptoms that requires a change of medication (antibiotics and/or systemic glucocorticoid) or hospitalisation.
Measured: 1 year
Secondary outcomes (1)
Number of hospitalisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Research Center for Respiratory Diseases, Fundación Mutua Madrileña
- Responsible party
- Principal investigator, Borja Cosio, Hospital Son Espases
- Investigators
- Borja G Cosio, MD, Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599871
- Sponsor's protocol ID
- 1559-F-447
- Acronym
- ASSET
- Status last verified
- Aug 2017
- First submitted
- 14 May 2012
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cosio BG, Shafiek H, Iglesias A, Yanez A, Cordova R, Palou A, Rodriguez-Roisin R, Peces-Barba G, Pascual S, Gea J, Sibila O, Barnes PJ, Agusti A. Oral Low-dose Theophylline on Top of Inhaled Fluticasone-Salmeterol Does Not Reduce Exacerbations in Patients With Severe COPD: A Pilot Clinical Trial. Chest. 2016 Jul;150(1):123-30. doi: 10.1016/j.chest.2016.04.011. Epub 2016 Apr 21.
PubMed 27107490
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter 52 Weeks Double Blind Placebo-controlled Trial for the Assessment of Theophylline on Top of Combination Therapy in Severe COPD
- ClinicalTrials.gov ID
- NCT01599871
- Acronym / sponsor ID
- ASSET / 1559-F-447
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Collaborators
- Spanish Research Center for Respiratory Diseases, Fundación Mutua Madrileña
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: theophyllineInhaled corticosteroids and long-acting beta agonist + theophylline (Slophylline capsules 100 mg/Theo-dur Retard 100 mg b.i.d.) |
| Control | Placebo comparator | Other: placeboinhaled corticosteroids and long-acting beta agonist + Placebo |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (9 listed)
- Presence or history of other chronic respiratory diseases (asthma, bronchiectasis, TB lesions)
- Cancer
- Heart failure
- Pregnancy, or risk of pregnancy
- Other inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| theophyllinetheophylline 100 mg, twice at day | Drug | Intervention |
| placeboPlacebo | Other | Control |
Primary outcome
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 secondary outcome
Number of hospitalisation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Derived from this study: PubMed 27107490Cosio BG, Shafiek H, Iglesias A, Yanez A, Cordova R, Palou A, Rodriguez-Roisin R, Peces-Barba G, Pascual S, Gea J, Sibila O, Barnes PJ, Agusti A. Oral Low-dose Theophylline on Top of Inhaled Fluticasone-Salmeterol Does Not Reduce Exacerbations in Patients With Severe COPD: A Pilot Clinical Trial. Chest. 2016 Jul;150(1):123-30. doi: 10.1016/j.chest.2016.04.011. Epub 2016 Apr 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borja G Cosio, MD principal investigator
Hospital Son Espases
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing theophylline in people with Chronic Obstructive Pulmonary Disease, run by Hospital Son Espases at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.