Healthy VolunteersPhase 1NCT01263808
Cardiac Safety of Indacaterol
A Phase 1 study testing Indacaterol 150 µg, Indacaterol 300 µg and Indacaterol 600 µg in people with Healthy Volunteers and Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol 150 µg, Indacaterol 300 µg and Indacaterol 600 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2008
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking
- Body mass index (BMI) 18.5-32 kg/m2
- Body weight at least 50 kg
Who cannot join
- Recent/concurrent use of concomitant medications (except acetaminophen)
- Recent participation in other clinical trials
- Recent donation or loss of blood
- History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
- Being tested
- Indacaterol 150 µg, Indacaterol 300 µg, Indacaterol 600 µg, Placebo, Placebo/moxifloxacin
- Keywords
- Indacaterol, Moxifloxacin
- 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 150 µgDrug
Once daily (QD) via single-dose dry powder inhaler (SDDPI)
Indacaterol 300 µgDrug
QD via SDDPI
Indacaterol 600 µgDrug
QD via SDDPI
PlaceboDrug
QD via SDDPI
Placebo/moxifloxacinDrug
Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol 150 µg | Experimental | Indacaterol 150 µg Receives: Drug: Indacaterol 150 µg |
| Indacaterol 300 µg | Experimental | Indacaterol 300 µg Receives: Drug: Indacaterol 300 µg |
| Indacaterol 600 µg | Experimental | Indacaterol 600 µg Receives: Drug: Indacaterol 600 µg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Placebo/moxifloxacin | Active comparator | Placebo/moxifloxacin Receives: Drug: Placebo/moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTc interval (Fridericia's)
Measured: Change from baseline (prior to the first dose) to Day 14
Secondary outcomes (1)
Change from baseline in uncorrected QT interval
Measured: Change from baseline (prior to the first dose) to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startApr 2008
- Primary completionAug 2008
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 Healthy VolunteersStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263808
- Sponsor's protocol ID
- CQAB149B2339
- Status last verified
- Dec 2010
- First submitted
- 17 Dec 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
Publications
Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31.
PubMed 21615886
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-dose, Placebo- and Positive-controlled Parallel Group Study to Evaluate the Effects of Indacaterol on Cardiac Safety in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01263808
- Acronym / sponsor ID
- CQAB149B2339
- Keywords
- Indacaterol, Moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- First posted
- 21 Dec 2010 (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.
This study compares the cardiac safety of inhaled indacaterol with that of placebo and oral moxifloxacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Indacaterol 150 µg | Experimental | Drug: Indacaterol 150 µgIndacaterol 150 µg |
| Indacaterol 300 µg | Experimental | Drug: Indacaterol 300 µgIndacaterol 300 µg |
| Indacaterol 600 µg | Experimental | Drug: Indacaterol 600 µgIndacaterol 600 µg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Placebo/moxifloxacin | Active comparator | Drug: Placebo/moxifloxacinPlacebo/moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking
- Body mass index (BMI) 18.5-32 kg/m2
- Body weight at least 50 kg
Key exclusion criteria (5 listed)
- Recent/concurrent use of concomitant medications (except acetaminophen)
- Recent participation in other clinical trials
- Recent donation or loss of blood
- History/presence of a range of medical conditions, including electrocardiographic (ECG) abnormalities, diabetes mellitus, hyperthyroidism and impaired renal function
- Other protocol-defined inclusion/exclusion criteria may apply
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 150 µgOnce daily (QD) via single-dose dry powder inhaler (SDDPI) | Drug | Indacaterol 150 µg |
| Indacaterol 300 µgQD via SDDPI | Drug | Indacaterol 300 µg |
| Indacaterol 600 µgQD via SDDPI | Drug | Indacaterol 600 µg |
| PlaceboQD via SDDPI | Drug | Placebo |
| Placebo/moxifloxacinPlacebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg | Drug | Placebo/moxifloxacin |
Primary outcome
Change from baseline in QTc interval (Fridericia's)
Time frame: Change from baseline (prior to the first dose) to Day 14
1 secondary outcome
Change from baseline in uncorrected QT interval
Time frame: Change from baseline (prior to the first dose) to Day 14
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 21 Dec 2010.
- Derived from this study: PubMed 21615886Khindri S, Sabo R, Harris S, Woessner R, Jennings S, Drollmann AF. Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study. BMC Pulm Med. 2011 May 26;11:31. doi: 10.1186/1471-2466-11-31.
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Screening Protocol
Pain
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?
A Phase 1 study testing Indacaterol 150 µg, Indacaterol 300 µg and Indacaterol 600 µg in people with Healthy Volunteers and Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 1 site in United States.
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 3 inclusion and 5 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 21 Dec 2010. 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 States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from baseline in QTc interval (Fridericia's) (time frame: Change from baseline (prior to the first dose) to Day 14). 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 NCT01263808, 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 21 Dec 2010.