Quality of LifePhase 3NCT04122040
Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis
A Phase 3 study testing Roxithromycin 300 MG in people with Quality of Life and Respiratory Function Tests, run by Prince of Songkla University.
Trial summary
roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Quality of Life, Respiratory Function Tests
- What is being tested?
- Roxithromycin 300 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2011to 30 Sep 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating
About this study
Official title: Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period
roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis
Read the detailed description
A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis
- Conditions
- Quality of Life, Respiratory Function Tests
- Being tested
- Roxithromycin 300 MG, Placebo
- Keywords
- Bronchiectasis, quality of life, pulmonary function tests
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roxithromycin 300 MGDrug
Also called Roxithromycin
Roxithromycin 300 mg oral per day
PlaceboDrug
Placebo one table oral once dialy
| Study group | Role | What they receive |
|---|---|---|
| roxithromycin | Active comparator | roxithromycin 300 mg oral per day Receives: Drug: Roxithromycin 300 MG |
| placebo | Placebo comparator | placebo one tablet per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGRQ scores
SGRQ scores
Measured: for 12 weeks
Secondary outcomes (2)
pulmonary function tests
FEV1
Measured: 24 weeks
sputum volumes
sputum volume per day
Measured: 24 wekse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Mar 2011
- Primary completion30 Sep 2011
- Study completion30 Sep 2011
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 Quality of LifeStudies 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
- Model description
- randomised control study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siwasak Juthong, Prince of Songkla University
- Investigators
- Kanung Saejiam, MS, Study director, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122040
- Sponsor's protocol ID
- 54-282-14-3-2
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nakamura H, Fujishima S, Inoue T, Ohkubo Y, Soejima K, Waki Y, Mori M, Urano T, Sakamaki F, Tasaka S, Ishizaka A, Kanazawa M, Yamaguchi K. Clinical and immunoregulatory effects of roxithromycin therapy for chronic respiratory tract infection. Eur Respir J. 1999 Jun;13(6):1371-9. doi: 10.1183/09031936.99.13613809.
PubMed 10445614
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period
- ClinicalTrials.gov ID
- NCT04122040
- Acronym / sponsor ID
- 54-282-14-3-2
- Conditions
- Quality of Life, Respiratory Function Tests
- Keywords
- Bronchiectasis, quality of life, pulmonary function tests
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 30 Sep 2011 (actual)
- Study completion
- 30 Sep 2011 (actual)
- First posted
- 10 Oct 2019 (actual)
- 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.
roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis
Detailed description
A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- randomised control study
| Arm | Type | Receives |
|---|---|---|
| roxithromycin | Active comparator | Drug: Roxithromycin 300 MGroxithromycin 300 mg oral per day |
| placebo | Placebo comparator | Drug: Placeboplacebo one tablet per day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating
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 |
|---|---|---|
| Roxithromycin 300 MGAlso: RoxithromycinRoxithromycin 300 mg oral per day | Drug | roxithromycin |
| PlaceboPlacebo one table oral once dialy | Drug | placebo |
Primary outcome
SGRQ scores
Time frame: for 12 weeks
SGRQ scores
2 secondary outcomes
pulmonary function tests
Time frame: 24 weeks
sputum volumes
Time frame: 24 wekse
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 14 Oct 2019.
- Background: PubMed 10445614Nakamura H, Fujishima S, Inoue T, Ohkubo Y, Soejima K, Waki Y, Mori M, Urano T, Sakamaki F, Tasaka S, Ishizaka A, Kanazawa M, Yamaguchi K. Clinical and immunoregulatory effects of roxithromycin therapy for chronic respiratory tract infection. Eur Respir J. 1999 Jun;13(6):1371-9. doi: 10.1183/09031936.99.13613809.
- Individual participant dataSharing planned: No
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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.
Kanung Saejiam, MS study director
Prince of Songkla University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roxithromycin 300 MG in people with Quality of Life and Respiratory Function Tests, run by Prince of Songkla University.
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 0 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 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
SGRQ scores (time frame: for 12 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 NCT04122040, 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 14 Oct 2019.