AsthmaPhase 2NCT00947453
Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast
A Phase 2 study testing montelukast in people with Asthma, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Dec 2011
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, aged 18 to 60 years.
- Diagnosed with asthma, defined as episodic chest tightness, wheezing and dyspnoea, cough.
- Non-Smoker or Ex-Smoker for at least 10 years and a smoking history of less than 5 pack years.
- History of asthma symptoms for more than 10years.
- Receiving as required short acting bronchodilators.
- Post bronchodilator FEV1 50 to 100 % predicted
- Evidence of airway calibre reversibility within the previous 12 months: reversibility to salbutamol of 12% following 400mcg inhaled salbutamol, histamine PC20 < 8mg/ml, diurnal variation in peak expiratory flow of 20%.
- Able to produce sputum after induction with saline.
Who cannot join
- Cardiac or pulmonary disease other than asthma.
- Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.
- Receiving inhaled or oral corticosteroid therapy, long acting Beta2 agonist therapy or leukotriene modifying therapy for the previous 1 month.
- Severe or uncontrolled co-morbid disease.
- Pregnancy or breastfeeding.
- Unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR47TJ
About this study
Official title: The Effect of Montelukast Therapy on mRNA Profile of Matrix Metalloproteinases and Their Inhibitors in the Sputum of Patients With Asthma
Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).
Read the detailed description
The following measurements will be performed at screening:
- Informed consent
- Clinical examination
- Spirometry
- Induced sputum
The following will be performed after 8 weeks of study medication:
- Clinical examination
- Spirometry
- Induced sputum
- Diary Card
Spirometry:
This will be performed with a Microlab spirometer (Micro Medical Ltd, Rochester, Kent, UK). The procedure will be according to American Thoracic Society specifications(13).
Diary Card Data:
Patients will record their symptoms on a daily basis in the morning according to "cough", "breathlessness" and "wheeze" on a 4 point scale with 0=no symptoms and 3=maximal symptoms. A total symptom score will be calculated out of 12. Patients will also measure their peak expiratory flow on a daily basis in the morning and record the highest of three measurements. They will record that they have taken their study medication.
Sputum Induction \& Examination:
Sputum will be obtained with hypertonic saline by the method described by Pizzichini et al(14) inhaling increasing concentrations of saline (3, 4 and 5%) each for 7 minutes, through a mouthpiece. After each period of inhalation, FEV1 will be measured for safety. Subjects will be asked to cough sputum into a sterile container. Total cell count of leukocytes will be obtained in a modified Neubauer haemocytometer. The cell viability will be determined by the trypan blue exclusion method. Four hundred non squamous cells will be counted in Wright-stained slides and the results will be expressed as a percentage and absolute number of the total non squamous count. Measurement of MMP-9, 12 TIMP-1 and TGFb will be performed in sputum supernatant.
Profile of mRNA of MMP and TIMPs:
Total RNA will be extracted from the cellular content of the induced sputum plug using a combination of Trizol extraction and Qiagen RNeasy spin columns in a similar way to previously described12. Quantitative RT-PCR, using previously developed primers and probes, will be used to determine the relative quantities of mRNA of MMPs and TIMPs as described12. We remain the only centre in the world to routinely profile the entire MMP and TIMP gene family in human samples. This gives an all encompassing view of the involvement of these enzymes and inhibitors in the disease process and also sheds light on potential new biomarkers. The possibility of expanding the gene profiling without the need for additional sputum collection also adds value to the research. This might include other proteinase families with roles in ECM breakdown or in inflammation.
- Conditions
- Asthma
- Being tested
- montelukast
- Keywords
- asthma, montelukast
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
montelukast 10 mg once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| montelukast group | Experimental | Identified patients with asthma to recieve Montelukast 10 mg (Merck Sharp \& Dohme Ltd, Herts, UK) at 0800 am once daily for 8 weeks. Receives: Drug: montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the MMP and TIMP mRNA profile relative to a housekeeping gene
Measured: 8 weeks
Secondary outcomes (3)
The difference between treatment with montelukast for 8 weeks and placebo for mRNA for MMP and TIMP
Measured: 8 weeks
The difference between treatment with montelukast for 8 weeks and placebo for Spirometry - FEV1, FVC, FEV1/FVC ratio
Measured: 8 weeks
The difference between treatment with montelukast for 8 weeks and placebo for Induced sputum differential cell count
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Investigators
- Andrew M Wilson, MRCP (UK), Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947453
- Sponsor's protocol ID
- 2009RESP01
- Other IDs
- EudraCT Number: 2008-008364-27
- Status last verified
- Aug 2012
- First submitted
- 24 Jul 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cauwe B, Van den Steen PE, Opdenakker G. The biochemical, biological, and pathological kaleidoscope of cell surface substrates processed by matrix metalloproteinases. Crit Rev Biochem Mol Biol. 2007 May-Jun;42(3):113-85. doi: 10.1080/10409230701340019.
PubMed 17562450Suzuki R, Miyazaki Y, Takagi K, Torii K, Taniguchi H. Matrix metalloproteinases in the pathogenesis of asthma and COPD: implications for therapy. Treat Respir Med. 2004;3(1):17-27. doi: 10.2165/00151829-200403010-00003.
PubMed 15174890Atkinson JJ, Senior RM. Matrix metalloproteinase-9 in lung remodeling. Am J Respir Cell Mol Biol. 2003 Jan;28(1):12-24. doi: 10.1165/rcmb.2002-0166TR.
PubMed 12495928Kelly EA, Busse WW, Jarjour NN. Increased matrix metalloproteinase-9 in the airway after allergen challenge. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1157-61. doi: 10.1164/ajrccm.162.3.9908016.
PubMed 10988146Boulay ME, Prince P, Deschesnes F, Chakir J, Boulet LP. Metalloproteinase-9 in induced sputum correlates with the severity of the late allergen-induced asthmatic response. Respiration. 2004 May-Jun;71(3):216-24. doi: 10.1159/000077418.
PubMed 15133340Beeh KM, Beier J, Kornmann O, Buhl R. Sputum matrix metalloproteinase-9, tissue inhibitor of metalloprotinease-1, and their molar ratio in patients with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and healthy subjects. Respir Med. 2003 Jun;97(6):634-9. doi: 10.1053/rmed.2003.1493.
PubMed 12814147Vignola AM, Riccobono L, Mirabella A, Profita M, Chanez P, Bellia V, Mautino G, D'accardi P, Bousquet J, Bonsignore G. Sputum metalloproteinase-9/tissue inhibitor of metalloproteinase-1 ratio correlates with airflow obstruction in asthma and chronic bronchitis. Am J Respir Crit Care Med. 1998 Dec;158(6):1945-50. doi: 10.1164/ajrccm.158.6.9803014.
PubMed 9847290Barnes PJ, Hansel TT. Prospects for new drugs for chronic obstructive pulmonary disease. Lancet. 2004 Sep 11-17;364(9438):985-96. doi: 10.1016/S0140-6736(04)17025-6.
PubMed 15364192Langlois A, Ferland C, Tremblay GM, Laviolette M. Montelukast regulates eosinophil protease activity through a leukotriene-independent mechanism. J Allergy Clin Immunol. 2006 Jul;118(1):113-9. doi: 10.1016/j.jaci.2006.03.010. Epub 2006 May 19.
PubMed 16815146Vignola AM, Riccobono L, Profita M, Foresi A, Di Giorgi R, Guerrera D, Gjomarkaj M, Di Blasi P, Paggiaro PL. Effects of low doses of inhaled fluticasone propionate on inflammation and remodelling in persistent-mild asthma. Allergy. 2005 Dec;60(12):1511-7. doi: 10.1111/j.1398-9995.2005.00827.x.
PubMed 16266383Chuang SS, Hung CH, Hua YM, Tien CH, Yang KD, Jong YJ, Hsu SH, Lin CS. Suppression of plasma matrix metalloproteinase-9 following montelukast treatment in childhood asthma. Pediatr Int. 2007 Dec;49(6):918-22. doi: 10.1111/j.1442-200X.2007.02497.x.
PubMed 18045297Kevorkian L, Young DA, Darrah C, Donell ST, Shepstone L, Porter S, Brockbank SM, Edwards DR, Parker AE, Clark IM. Expression profiling of metalloproteinases and their inhibitors in cartilage. Arthritis Rheum. 2004 Jan;50(1):131-41. doi: 10.1002/art.11433.
PubMed 14730609Standardization of spirometry--1987 update. Statement of the American Thoracic Society. Am Rev Respir Dis. 1987 Nov;136(5):1285-98. doi: 10.1164/ajrccm/136.5.1285. No abstract available.
PubMed 3674589Pizzichini E, Pizzichini MM, Efthimiadis A, Evans S, Morris MM, Squillace D, Gleich GJ, Dolovich J, Hargreave FE. Indices of airway inflammation in induced sputum: reproducibility and validity of cell and fluid-phase measurements. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):308-17. doi: 10.1164/ajrccm.154.2.8756799.
PubMed 8756799
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Montelukast Therapy on mRNA Profile of Matrix Metalloproteinases and Their Inhibitors in the Sputum of Patients With Asthma
- ClinicalTrials.gov ID
- NCT00947453
- Acronym / sponsor ID
- 2009RESP01
- Conditions
- Asthma
- Keywords
- asthma, montelukast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jul 2009 (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.
Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).
Detailed description
The following measurements will be performed at screening:
- Informed consent
- Clinical examination
- Spirometry
- Induced sputum
The following will be performed after 8 weeks of study medication:
- Clinical examination
- Spirometry
- Induced sputum
- Diary Card
Spirometry:
This will be performed with a Microlab spirometer (Micro Medical Ltd, Rochester, Kent, UK). The procedure will be according to American Thoracic Society specifications(13).
Diary Card Data:
Patients will record their symptoms on a daily basis in the morning according to "cough", "breathlessness" and "wheeze" on a 4 point scale with 0=no symptoms and 3=maximal symptoms. A total symptom score will be calculated out of 12. Patients will also measure their peak expiratory flow on a daily basis in the morning and record the highest of three measurements. They will record that they have taken their study medication.
Sputum Induction \& Examination:
Sputum will be obtained with hypertonic saline by the method described by Pizzichini et al(14) inhaling increasing concentrations of saline (3, 4 and 5%) each for 7 minutes, through a mouthpiece. After each period of inhalation, FEV1 will be measured for safety. Subjects will be asked to cough sputum into a sterile container. Total cell count of leukocytes will be obtained in a modified Neubauer haemocytometer. The cell viability will be determined by the trypan blue exclusion method. Four hundred non squamous cells will be counted in Wright-stained slides and the results will be expressed as a percentage and absolute number of the total non squamous count. Measurement of MMP-9, 12 TIMP-1 and TGFb will be performed in sputum supernatant.
Profile of mRNA of MMP and TIMPs:
Total RNA will be extracted from the cellular content of the induced sputum plug using a combination of Trizol extraction and Qiagen RNeasy spin columns in a similar way to previously described12. Quantitative RT-PCR, using previously developed primers and probes, will be used to determine the relative quantities of mRNA of MMPs and TIMPs as described12. We remain the only centre in the world to routinely profile the entire MMP and TIMP gene family in human samples. This gives an all encompassing view of the involvement of these enzymes and inhibitors in the disease process and also sheds light on potential new biomarkers. The possibility of expanding the gene profiling without the need for additional sputum collection also adds value to the research. This might include other proteinase families with roles in ECM breakdown or in inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| montelukast group | Experimental | Drug: montelukastIdentified patients with asthma to recieve Montelukast 10 mg (Merck Sharp \& Dohme Ltd, Herts, UK) at 0800 am once daily for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, aged 18 to 60 years.
- Diagnosed with asthma, defined as episodic chest tightness, wheezing and dyspnoea, cough.
- Non-Smoker or Ex-Smoker for at least 10 years and a smoking history of less than 5 pack years.
- History of asthma symptoms for more than 10years.
- Receiving as required short acting bronchodilators.
Key exclusion criteria (6 listed)
- Cardiac or pulmonary disease other than asthma.
- Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.
- Receiving inhaled or oral corticosteroid therapy, long acting Beta2 agonist therapy or leukotriene modifying therapy for the previous 1 month.
- Severe or uncontrolled co-morbid disease.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| montelukastmontelukast 10 mg once daily for 8 weeks | Drug | montelukast group |
Primary outcome
Primary endpoint is the MMP and TIMP mRNA profile relative to a housekeeping gene
Time frame: 8 weeks
3 secondary outcomes
The difference between treatment with montelukast for 8 weeks and placebo for mRNA for MMP and TIMP
Time frame: 8 weeks
The difference between treatment with montelukast for 8 weeks and placebo for Spirometry - FEV1, FVC, FEV1/FVC ratio
Time frame: 8 weeks
The difference between treatment with montelukast for 8 weeks and placebo for Induced sputum differential cell count
Time frame: 8 weeks
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 23 Aug 2012.
- Background: PubMed 17562450Cauwe B, Van den Steen PE, Opdenakker G. The biochemical, biological, and pathological kaleidoscope of cell surface substrates processed by matrix metalloproteinases. Crit Rev Biochem Mol Biol. 2007 May-Jun;42(3):113-85. doi: 10.1080/10409230701340019.
- Background: PubMed 15174890Suzuki R, Miyazaki Y, Takagi K, Torii K, Taniguchi H. Matrix metalloproteinases in the pathogenesis of asthma and COPD: implications for therapy. Treat Respir Med. 2004;3(1):17-27. doi: 10.2165/00151829-200403010-00003.
- Background: PubMed 12495928Atkinson JJ, Senior RM. Matrix metalloproteinase-9 in lung remodeling. Am J Respir Cell Mol Biol. 2003 Jan;28(1):12-24. doi: 10.1165/rcmb.2002-0166TR.
- Background: PubMed 10988146Kelly EA, Busse WW, Jarjour NN. Increased matrix metalloproteinase-9 in the airway after allergen challenge. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1157-61. doi: 10.1164/ajrccm.162.3.9908016.
- Background: PubMed 15133340Boulay ME, Prince P, Deschesnes F, Chakir J, Boulet LP. Metalloproteinase-9 in induced sputum correlates with the severity of the late allergen-induced asthmatic response. Respiration. 2004 May-Jun;71(3):216-24. doi: 10.1159/000077418.
- Background: PubMed 12814147Beeh KM, Beier J, Kornmann O, Buhl R. Sputum matrix metalloproteinase-9, tissue inhibitor of metalloprotinease-1, and their molar ratio in patients with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and healthy subjects. Respir Med. 2003 Jun;97(6):634-9. doi: 10.1053/rmed.2003.1493.
- Background: PubMed 9847290Vignola AM, Riccobono L, Mirabella A, Profita M, Chanez P, Bellia V, Mautino G, D'accardi P, Bousquet J, Bonsignore G. Sputum metalloproteinase-9/tissue inhibitor of metalloproteinase-1 ratio correlates with airflow obstruction in asthma and chronic bronchitis. Am J Respir Crit Care Med. 1998 Dec;158(6):1945-50. doi: 10.1164/ajrccm.158.6.9803014.
- Background: PubMed 15364192Barnes PJ, Hansel TT. Prospects for new drugs for chronic obstructive pulmonary disease. Lancet. 2004 Sep 11-17;364(9438):985-96. doi: 10.1016/S0140-6736(04)17025-6.
- Background: PubMed 16815146Langlois A, Ferland C, Tremblay GM, Laviolette M. Montelukast regulates eosinophil protease activity through a leukotriene-independent mechanism. J Allergy Clin Immunol. 2006 Jul;118(1):113-9. doi: 10.1016/j.jaci.2006.03.010. Epub 2006 May 19.
- Background: PubMed 16266383Vignola AM, Riccobono L, Profita M, Foresi A, Di Giorgi R, Guerrera D, Gjomarkaj M, Di Blasi P, Paggiaro PL. Effects of low doses of inhaled fluticasone propionate on inflammation and remodelling in persistent-mild asthma. Allergy. 2005 Dec;60(12):1511-7. doi: 10.1111/j.1398-9995.2005.00827.x.
- Background: PubMed 18045297Chuang SS, Hung CH, Hua YM, Tien CH, Yang KD, Jong YJ, Hsu SH, Lin CS. Suppression of plasma matrix metalloproteinase-9 following montelukast treatment in childhood asthma. Pediatr Int. 2007 Dec;49(6):918-22. doi: 10.1111/j.1442-200X.2007.02497.x.
- Background: PubMed 14730609Kevorkian L, Young DA, Darrah C, Donell ST, Shepstone L, Porter S, Brockbank SM, Edwards DR, Parker AE, Clark IM. Expression profiling of metalloproteinases and their inhibitors in cartilage. Arthritis Rheum. 2004 Jan;50(1):131-41. doi: 10.1002/art.11433.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Andrew M Wilson, MRCP (UK) principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing montelukast in people with Asthma, run by University of East Anglia at 1 site in United Kingdom.
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 6 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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?
Primary endpoint is the MMP and TIMP mRNA profile relative to a housekeeping gene (time frame: 8 weeks). 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 NCT00947453, which also lists 14 linked publications.
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 23 Aug 2012.