Chronic Obstructive Pulmonary DiseasePhase 2NCT00634413
Effect of ADC4022 Co-Administered With Budesonide on Pulmonary Inflammation in Subjects With Moderate to Severe COPD
A Phase 2 study testing Theophylline - ADC4022 and Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Pulmagen Therapeutics at 8 sites in 2 countries.
Trial summary
The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Theophylline - ADC4022 and Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 2
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of COPD that has been symptomatic for at least 2 years
- The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society
- The subject can produce an adequate sputum specimen after induction
- The subject has a history of ≥ 10-pack years of cigarette smoking
- The subject has either a ≤15% increase or ≤200 ml increase in FEV1 from pre-dose following a fixed dose of bronchodilator therapy
- The subject is able to provide written, informed consent to participate
Who cannot join
- The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days
- The subject uses systemic corticosteroids (oral or parenteral)
- The subject has received long term oxygen therapy within 30 days
- The subject has a previous history or diagnosis of asthma
- The subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than COPD
- The subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases
Show all 12Show fewer
- The subject has had radiation or chemotherapy within the previous 12 months
- The subject has a history of anaphylaxis associated with medicinal products
- The subject is pregnant, intends to become pregnant, or is breast feeding
- The subject's alcohol intake is excessive.
- The subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study.
- Other inclusion/exclusion criteria may also apply
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Poland5 sites
Silisian Medical University
Katowice-Ligota, Katowice-Ligota, 40-752
Jagiellonian University of Medicine
Krakow, Krakow, 31-066
Medical University in Lodz
Lodz, Łódź Voivodeship, 90-153
National Tuberculosis and Lung Diseases Research Institute
Warsaw, Warsaw, 01-138
Warsaw University Medical School
Warsaw, Warsaw, 02-097
United Kingdom3 sites
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
The London Chest Hospital
London, London, E2 9JX
Medicines Evaluation Unit
Manchester, Manchester, M23 9QZ
About this study
Official title: A Phase II, Randomised, Double-Blind, Placebo-Controlled Pilot Efficacy Study of ADC4022 on Markers of Pulmonary Inflammation in Subjects With Moderate to Severe COPD
The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Theophylline - ADC4022, Placebo, Budesonide
- 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.
Theophylline - ADC4022Drug
Also called ADC4022
Inhaled theophylline (ADC4022) administered twice daily for 28 days
PlaceboDrug
Inhaled matching placebo administered twice daily for 28 days
BudesonideDrug
Also called Pulmicort
Inhaled budesonide twice daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Theophylline - ADC4022; Drug: Budesonide |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
Measured: Baseline and after 4 weeks treatment
Secondary outcomes (3)
Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
Measured: Baseline and after 4 weeks treatment
Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
Measured: Baseline and after 4 weeks treatment
Tolerability to ADC4022
Measured: Baseline, during 4 weeks treatment and after 1 week of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmagen Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Neil Barnes, MD PhD, Principal investigator, London Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634413
- Sponsor's protocol ID
- ADC_4022_CLIN_02P
- Status last verified
- Feb 2009
- First submitted
- 6 Mar 2008
- Last updated
- 2 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-Blind, Placebo-Controlled Pilot Efficacy Study of ADC4022 on Markers of Pulmonary Inflammation in Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT00634413
- Acronym / sponsor ID
- ADC_4022_CLIN_02P
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Pulmagen TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Mar 2008 (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 purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Theophylline - ADC4022, Drug: Budesonide |
| 2 | Placebo comparator | Drug: Placebo, Drug: Budesonide |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of COPD that has been symptomatic for at least 2 years
- The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society
- The subject can produce an adequate sputum specimen after induction
- The subject has a history of ≥ 10-pack years of cigarette smoking
- The subject has either a ≤15% increase or ≤200 ml increase in FEV1 from pre-dose following a fixed dose of bronchodilator therapy
Key exclusion criteria (12 listed)
- The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days
- The subject uses systemic corticosteroids (oral or parenteral)
- The subject has received long term oxygen therapy within 30 days
- The subject has a previous history or diagnosis of asthma
- The subject has a chest x-ray within the past 12 months which is diagnostic of an active or clinically significant disease other than COPD
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 |
|---|---|---|
| Theophylline - ADC4022Also: ADC4022Inhaled theophylline (ADC4022) administered twice daily for 28 days | Drug | 1 |
| PlaceboInhaled matching placebo administered twice daily for 28 days | Drug | 2 |
| BudesonideAlso: PulmicortInhaled budesonide twice daily for 28 days | Drug | 1, 2 |
Primary outcome
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
Time frame: Baseline and after 4 weeks treatment
3 secondary outcomes
Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
Time frame: Baseline and after 4 weeks treatment
Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
Time frame: Baseline and after 4 weeks treatment
Tolerability to ADC4022
Time frame: Baseline, during 4 weeks treatment and after 1 week of follow-up
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 2 Mar 2009.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Neil Barnes, MD PhD principal investigator
London Chest Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Theophylline - ADC4022 and Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Pulmagen Therapeutics at 8 sites in 2 countries.
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 6 inclusion and 12 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 2 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples (time frame: Baseline and after 4 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2009.