AsthmaPhase 2NCT00605306
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
A Phase 2 study testing indacaterol maleate / mometasone furoate in people with Asthma, run by Novartis at 3 sites in France.
Trial summary
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- indacaterol maleate / mometasone furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2008to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult patients aged 18-65 years (inclusive)
- Patients with mild-moderate asthma
- Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range of 18-32 kg/m^2.
- Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.
Who cannot join
- Patients who suffer from chronic obstructive pulmonary disease (COPD)
- Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
- QTcF interval > 450 msec in men and >470 msec in women
- Pregnant women or nursing mothers
- Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
- History of immunocompromise, including a positive human immunodeficiency virus (HIV)
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- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within 12 months of dosing
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Novartis Investigator Site
Neuil
Novartis Investigator Site
Paris
Novartis Investigator Site
Poitiers
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
- Conditions
- Asthma
- Being tested
- indacaterol maleate / mometasone furoate, placebo to indacaterol maleate/mometasone furoate
- Keywords
- Asthma, spirometry, lung function, serum cortisol, serum potassium, plasma glucose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indacaterol maleate / mometasone furoateDrug
Also called QMF149
Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
placebo to indacaterol maleate/mometasone furoateDrug
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
| Study group | Role | What they receive |
|---|---|---|
| indacaterol maleate/mometasone furoate | Experimental | Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. Receives: Drug: indacaterol maleate / mometasone furoate |
| Placebo | Placebo comparator | Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days. Receives: Drug: placebo to indacaterol maleate/mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.
A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: 15 days
Secondary outcomes (3)
Levels of Serum Potassium Over Time
At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Measured: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Levels of Plasma Glucose Over Time
At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Measured: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Levels of Serum Cortisol Over Time
At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Measured: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- NOVARTIS, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605306
- Sponsor's protocol ID
- CQMF149A2203
- Status last verified
- Mar 2013
- First submitted
- 18 Jan 2008
- Last updated
- 22 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00605306
- Acronym / sponsor ID
- CQMF149A2203
- Conditions
- Asthma
- Keywords
- Asthma, spirometry, lung function, serum cortisol, serum potassium, plasma glucose
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Jan 2008 (estimated)
- Results
- Posted 22 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indacaterol maleate/mometasone furoate | Experimental | Drug: indacaterol maleate / mometasone furoateParticipants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. |
| Placebo | Placebo comparator | Drug: placebo to indacaterol maleate/mometasone furoateParticipants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adult patients aged 18-65 years (inclusive)
- Patients with mild-moderate asthma
- Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range of 18-32 kg/m^2.
- Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.
Key exclusion criteria (9 listed)
- Patients who suffer from chronic obstructive pulmonary disease (COPD)
- Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
- QTcF interval > 450 msec in men and >470 msec in women
- Pregnant women or nursing mothers
- Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
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 maleate / mometasone furoateAlso: QMF149Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device. | Drug | indacaterol maleate/mometasone furoate |
| placebo to indacaterol maleate/mometasone furoatePlacebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device. | Drug | Placebo |
Primary outcome
Participants With Adverse Events
Time frame: 15 days
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
3 secondary outcomes
Levels of Serum Potassium Over Time
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Levels of Plasma Glucose Over Time
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Levels of Serum Cortisol Over Time
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 principal investigator
Novartis investigator site
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing indacaterol maleate / mometasone furoate in people with Asthma, run by Novartis at 3 sites in France.
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 5 inclusion and 9 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Adverse Events (time frame: 15 days). 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 22 Apr 2013.