Chronic Obstructive Pulmonary DiseasePhase 2NCT00507949
Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of Weight
A Phase 2 study testing Megestrol acetate in people with Chronic Obstructive Pulmonary Disease, run by Rottapharm Spain at 1 site in Spain.
Trial summary
The purpose of this trial is to study the effect of megestrol acetate in the gain of body weight in patients with severe Chronic obstructive pulmonary disease in order to improve the survival of the patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Megestrol acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2006to Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnose of COPD (criteria ATS/ERS 2004)
- Clinical stability more than 3 months
- Smokers or ex-smokers of more than > 10 boxes/year than do not modify their smoking habit during the study.
- FEV1 (post-bronchodilator) < 50%. FEV1/FVC ≤ 70
- Negative answer to bronchodilator(≤ 20% del FEV1 o ≤ 200 ml.after 400 mcg.de salbutamol inhaled)
- BMI < 21 Kg/m2 ó BMI 21-25 Kg/m with loss weight of 5% of the habitual body weight in the last 3 months, without other reason that could explain it independently of the COPD.
Who cannot join
- Use of nasogastric catheter
- Concomitant treatment with steroid, anabolics or other progestagens.
- Loss of body weight related with other causes: hyperthyroidism, enteral malnutrition ( Crohn disease...), neoplasias,etc
- Treatment with Megestrol Acetate in the last 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site
Neumology Service of the Hospital Universitario Dr. Peset
Valencia, Valencia, 46017
About this study
Official title: Randomized Trial,Comparative With Placebo, Double Blind, to Evaluate the Effect of the Treatment With 320 mg/d of Megestrol Acetate in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) and Loss of Body Weight. Pilot Study
The purpose of this trial is to study the effect of megestrol acetate in the gain of body weight in patients with severe Chronic obstructive pulmonary disease in order to improve the survival of the patients.
Read the detailed description
It has been demonstrated that the body weight measured as a Body mass index (BMI)is an independent risk factor of mortality in the severe COPD.It seems to be one influence of inflammatory factors in the development of denutrition in these patients.
The use of especial diets has no so good results in the aim to improve the weight, being necessary to complement with muscular rehabilitation or anabolic products. The megestrol acetate has demonstrated good results in a short period of time, nevertheless the studies are scarce.
The beneficial effects of the megestrol acetate seems to be mediated by cytokines.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Megestrol acetate, placebo
- Keywords
- COPD, body weight, megestrol acetate, cytokines
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol acetateDrug
Sachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks.
placeboDrug
sachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Megestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks Receives: Drug: Megestrol acetate |
| 2 | Placebo comparator | The placebo is the excipient of the experimental drug. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate if the Megestrol Acetate administered in dose of 320 mg/d could produce a significative increase of body weight in patients with severe COPD with loss of weight without any known reason in the last 3 months.
Measured: 8 weeks
Secondary outcomes (3)
Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters
Measured: 8 weeks
Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.
Measured: 8 weeks
Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)
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 posted27 Jul 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2009
- Study completionSep 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Herrejon Alberto, MD, Principal investigator, Hospital Universitario Dr. Peset, Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507949
- Sponsor's protocol ID
- BO-EC-EPOC-01
- Other IDs
- EudraCT number:2005-005148-16
- Status last verified
- Jun 2011
- First submitted
- 26 Jul 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Herrejon A, Palop J, Inchaurraga I, Lopez A, Banuls C, Hernandez A, Blanquer R, Estan N, Anguera A. [Low doses of megestrol acetate increase weight and improve nutrition status in patients with severe chronic obstructive pulmonary disease and weight loss]. Med Clin (Barc). 2011 Jul 23;137(5):193-8. doi: 10.1016/j.medcli.2011.02.016. Epub 2011 Apr 27. Spanish.
PubMed 21524765
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial,Comparative With Placebo, Double Blind, to Evaluate the Effect of the Treatment With 320 mg/d of Megestrol Acetate in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) and Loss of Body Weight. Pilot Study
- ClinicalTrials.gov ID
- NCT00507949
- Acronym / sponsor ID
- BO-EC-EPOC-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, body weight, megestrol acetate, cytokines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jul 2007 (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 trial is to study the effect of megestrol acetate in the gain of body weight in patients with severe Chronic obstructive pulmonary disease in order to improve the survival of the patients.
Detailed description
It has been demonstrated that the body weight measured as a Body mass index (BMI)is an independent risk factor of mortality in the severe COPD.It seems to be one influence of inflammatory factors in the development of denutrition in these patients.
The use of especial diets has no so good results in the aim to improve the weight, being necessary to complement with muscular rehabilitation or anabolic products. The megestrol acetate has demonstrated good results in a short period of time, nevertheless the studies are scarce.
The beneficial effects of the megestrol acetate seems to be mediated by cytokines.
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: Megestrol acetateMegestrol acetate: sachets of granulated 160 mg. Dose: 160 mg/b.i.d. Duration 8 weeks |
| 2 | Placebo comparator | Drug: placeboThe placebo is the excipient of the experimental drug. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnose of COPD (criteria ATS/ERS 2004)
- Clinical stability more than 3 months
- Smokers or ex-smokers of more than > 10 boxes/year than do not modify their smoking habit during the study.
- FEV1 (post-bronchodilator) < 50%. FEV1/FVC ≤ 70
- Negative answer to bronchodilator(≤ 20% del FEV1 o ≤ 200 ml.after 400 mcg.de salbutamol inhaled)
Key exclusion criteria (4 listed)
- Use of nasogastric catheter
- Concomitant treatment with steroid, anabolics or other progestagens.
- Loss of body weight related with other causes: hyperthyroidism, enteral malnutrition ( Crohn disease...), neoplasias,etc
- Treatment with Megestrol Acetate in the last 6 months
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 |
|---|---|---|
| Megestrol acetateSachets of 160 mg of granulated. Dosage 160 mg /b.i.d. Duration 8 weeks. | Drug | 1 |
| placebosachets of granulate of 160 mg. Dosage 160 mg b.i.d. Duration 8 weeks. | Drug | 2 |
Primary outcome
To demonstrate if the Megestrol Acetate administered in dose of 320 mg/d could produce a significative increase of body weight in patients with severe COPD with loss of weight without any known reason in the last 3 months.
Time frame: 8 weeks
3 secondary outcomes
Evaluate if the gain of weight is correlated with an improvement of the functional respiratory parameters
Time frame: 8 weeks
Evaluate if the gain of weight is related with an improvement in the quality of life of the patients.
Time frame: 8 weeks
Evaluate the changes in the inflammatory parameters (IL-6, TNF alfa...)and nutritional ones (Albumin and prealbumin)
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 8 Jun 2011.
- Results publication: PubMed 21524765Herrejon A, Palop J, Inchaurraga I, Lopez A, Banuls C, Hernandez A, Blanquer R, Estan N, Anguera A. [Low doses of megestrol acetate increase weight and improve nutrition status in patients with severe chronic obstructive pulmonary disease and weight loss]. Med Clin (Barc). 2011 Jul 23;137(5):193-8. doi: 10.1016/j.medcli.2011.02.016. Epub 2011 Apr 27. Spanish.
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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.
Herrejon Alberto, MD principal investigator
Hospital Universitario Dr. Peset, Valencia
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 Megestrol acetate in people with Chronic Obstructive Pulmonary Disease, run by Rottapharm Spain at 1 site 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 6 inclusion and 4 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 8 Jun 2011. 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 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 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?
To demonstrate if the Megestrol Acetate administered in dose of 320 mg/d could produce a significative increase of body weight in patients with severe COPD with loss of weight without any known reason in the last 3 months. (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 NCT00507949, 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 8 Jun 2011.