Chronic Obstructive Pulmonary DiseasePhase 4NCT01010178
Can Airflow Limitation in Chronic Obstructive Pulmonary Disease (COPD) be Reversible by Drugs?
A Phase 4 study testing Macrolid, Theophylline, Inhaler Corticosteroids in people with Chronic Obstructive Pulmonary Disease, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
Critical combination of various approved drugs in management for patients suffering with COPD. Read more about this study
- Who is it for?
- Ages 22 to 86 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Macrolid, Theophylline, Inhaler Corticosteroids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIran
- Study dates
- Feb 2008to Jul 2009
- Phase
- Phase 4
- 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 22 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- current or past smoker COPD
Who cannot join
- history of significant occupational or other environmental exposures or a connective tissue disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University, Mollasadra St,
Tehran, 19945-546
About this study
Official title: Combination of Approved Drug in COPD
Critical combination of various approved drugs in management for patients suffering with COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Macrolid, Theophylline, Inhaler Corticosteroids
- Keywords
- COPD, Macrolid, reversibility, Theophylline, Corticosteroids, symptoms PFT
- 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.
Macrolid, Theophylline, Inhaler CorticosteroidsDrug
we have no permission to include them in detail because of privacy policy of mentioned journal for publication
| Study group | Role | What they receive |
|---|---|---|
| Macrolid, Theophylline, Corticosteroids | Experimental | Approved drug in this setting Receives: Drug: Macrolid, Theophylline, Inhaler Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
15% increasing in forced expiratory volume in 1 second
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionJul 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010178
- Sponsor's protocol ID
- BMT-1388-2
- Status last verified
- Nov 2009
- First submitted
- 6 Nov 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Approved Drug in COPD
- ClinicalTrials.gov ID
- NCT01010178
- Acronym / sponsor ID
- BMT-1388-2
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Macrolid, reversibility, Theophylline, Corticosteroids, symptoms PFT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Nov 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.
Critical combination of various approved drugs in management for patients suffering with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macrolid, Theophylline, Corticosteroids | Experimental | Drug: Macrolid, Theophylline, Inhaler CorticosteroidsApproved drug in this setting |
Who may qualify
- Ages
- 22 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- current or past smoker COPD
Key exclusion criteria (1 listed)
- history of significant occupational or other environmental exposures or a connective tissue disease
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 |
|---|---|---|
| Macrolid, Theophylline, Inhaler Corticosteroidswe have no permission to include them in detail because of privacy policy of mentioned journal for publication | Drug | Macrolid, Theophylline, Corticosteroids |
Primary outcome
15% increasing in forced expiratory volume in 1 second
Time frame: 6 months
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 9 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Macrolid, Theophylline, Inhaler Corticosteroids in people with Chronic Obstructive Pulmonary Disease, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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 1 inclusion and 1 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 9 Nov 2009. 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
15% increasing in forced expiratory volume in 1 second (time frame: 6 months). 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 9 Nov 2009.