Chronic Obstructive Pulmonary DiseaseINHALENCT02123199
Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
Trial summary
A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol (Onbrez®) /QAB149
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Dec 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be recruited only after indacaterol has been prescribed and is being used for the patients first maintenance therapy for COPD symptoms.
Who may be able to join
- Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes
Who cannot join
- Patients who are currently receiving other maintenance therapy (except LAMA) for COPD.
- Patients previously prescribed Indacaterol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol (Onbrez®) /QAB149
- 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.
Indacaterol (Onbrez®) /QAB149Drug
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol/QAB149 | Patients treated with Indacaterol for COPD prior to enrollment in study Receives: Drug: Indacaterol (Onbrez®) /QAB149 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol
Measured: 6-8 weeks
Secondary outcomes (4)
Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol
Measured: 6 months
Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.
Measured: 6-8 weeks
Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months.
Measured: 6-8 weeks and 6 months
Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months
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 posted25 Apr 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2013
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123199
- Sponsor's protocol ID
- CQAB149BGB01
- Acronym
- INHALE
- Status last verified
- Apr 2014
- First submitted
- 22 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD
- ClinicalTrials.gov ID
- NCT02123199
- Acronym / sponsor ID
- INHALE / CQAB149BGB01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 25 Apr 2014 (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.
A prospective observational multi centre research study in GP practices clustered within up to 10 UK Primary care trusts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indacaterol/QAB149 | – | Drug: Indacaterol (Onbrez®) /QAB149Patients treated with Indacaterol for COPD prior to enrollment in study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be recruited only after indacaterol has been prescribed and is being used for the patients first maintenance therapy for COPD symptoms.
Key inclusion criteria (1 listed)
- Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes
Key exclusion criteria (2 listed)
- Patients who are currently receiving other maintenance therapy (except LAMA) for COPD.
- Patients previously prescribed Indacaterol.
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 |
|---|---|---|
| Indacaterol (Onbrez®) /QAB149 | Drug | Indacaterol/QAB149 |
Primary outcome
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol
Time frame: 6-8 weeks
4 secondary outcomes
Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol
Time frame: 6 months
Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.
Time frame: 6-8 weeks
Physician Global Evaluation of Treatment effectiveness (GETE) at 6-8 weeks and 6 months.
Time frame: 6-8 weeks and 6 months
Patient Global Evaluation of Treatment effectiveness (GETE) at 6 months
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 25 Apr 2014.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals 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 1 inclusion and 2 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 25 Apr 2014. 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.
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?
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol (time frame: 6-8 weeks). 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 25 Apr 2014.