AsthmaPhase 1NCT00624702
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
A Phase 1 study testing Indacaterol maleate in people with Asthma, run by Novartis at 2 sites in Canada.
Trial summary
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2008to Sep 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 65 years old (inclusive)
- Patients with mild to moderate persistent asthma
- BMI must be within the range of 18-32 kg/m2 inclusive
- Female subjects must:
- have been sterilized at least 6 months prior to screening
- be post-menopausal with no regular bleeding for at least a year prior to inclusion
Who cannot join
- Patients with life-threatening arrhythmias
- Patients with COPD or diabetes mellitus
- History of immunocompromise, including a positive HIV
- A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Novartis Investigator Site
Montreal, Quebec
Novartis Investigator Site
Ottawa, Ontario
About this study
Official title: A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
- Conditions
- Asthma
- Being tested
- Indacaterol maleate, Placebo
- Keywords
- Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)
- Medical subject headings
- Asthma, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol maleateDrug
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Indacaterol maleateDrug
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Indacaterol maleateDrug
Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active Comparator 1 different salt formulation of Indacaterol. Receives: Drug: Indacaterol maleate |
| 2 | Active comparator | Active Comparator 2 different salt formulation of Indacaterol. Receives: Drug: Indacaterol maleate |
| 3 | Active comparator | Active Comparator 3 different salt formulation of Indacaterol. Receives: Drug: Indacaterol maleate |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Measured: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
Measured: throughout the study
Occurrence of cough within 1 minute post dose
Measured: throughout the study
Number of coughs
Measured: throughout the study
Duration of coughing
Measured: throughout the study
Secondary outcomes (5)
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Measured: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
Measured: throughout the study
Occurrence of cough within 1 minute post dose
Measured: throughout the study
Number of coughs
Measured: throughout the study
Duration of coughing
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Novartis investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624702
- Sponsor's protocol ID
- CQAB149B2102
- Status last verified
- Aug 2010
- First submitted
- 15 Feb 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT00624702
- Acronym / sponsor ID
- CQAB149B2102
- Conditions
- Asthma
- Keywords
- Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 27 Feb 2008 (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 will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Indacaterol maleateActive Comparator 1 different salt formulation of Indacaterol. |
| 2 | Active comparator | Drug: Indacaterol maleateActive Comparator 2 different salt formulation of Indacaterol. |
| 3 | Active comparator | Drug: Indacaterol maleateActive Comparator 3 different salt formulation of Indacaterol. |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients 18 to 65 years old (inclusive)
- Patients with mild to moderate persistent asthma
- BMI must be within the range of 18-32 kg/m2 inclusive
- Female subjects must:
Key exclusion criteria (5 listed)
- Patients with life-threatening arrhythmias
- Patients with COPD or diabetes mellitus
- History of immunocompromise, including a positive HIV
- A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result
- 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 maleateFour single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval | Drug | 1 |
| Indacaterol maleateFour single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval | Drug | 2 |
| Indacaterol maleateFour single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval | Drug | 3 |
| Placebo | Drug | 4 |
Primary outcome
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Time frame: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
Time frame: throughout the study
Occurrence of cough within 1 minute post dose
Time frame: throughout the study
Number of coughs
Time frame: throughout the study
Duration of coughing
Time frame: throughout the study
5 secondary outcomes
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
Time frame: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
Time frame: throughout the study
Occurrence of cough within 1 minute post dose
Time frame: throughout the study
Number of coughs
Time frame: throughout the study
Duration of coughing
Time frame: throughout the study
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 19 Dec 2020.
- Results for QAB149B2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
2 sites 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 maleate in people with Asthma, run by Novartis at 2 sites in Canada.
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 6 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation) (time frame: throughout the study). The study lists 5 primary outcomes in all. 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 19 Dec 2020.