Chronic Obstructive Pulmonary DiseasePhase 2NCT00636961
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
A Phase 2 study testing Indacaterol 300μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 3 sites in Germany.
Trial summary
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol 300μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2008to Aug 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects,
- 40 to 80 years of age,
- with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
- Subjects who demonstrate a plethysmographic functional residual capacity >120% predicted normal
Who cannot join
- No COPD exacerbations within 6 weeks prior to dosing,
- no concomitant lung disease such as asthma,
- no requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
- Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Novartis Investigator Site
Berlin
Novartis Investigator Site
Mönchengladbach
Novartis Investigator Site
Wiesbaden
About this study
Official title: An Exploratory, Double Blind, Randomized, Placebo-controlled, 2-way Cross-over Study to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With COPD
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol 300μg, Placebo
- Keywords
- COPD, Indacaterol Maleate, Exercise testing
- 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 300μgDrug
Also called Arcapta
300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device
PlaceboDrug
Matching placebo devices and hard gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Indacaterol 300μg followed by Placebo | Experimental | In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. Receives: Drug: Indacaterol 300μg; Drug: Placebo |
| Sequence 2 : Placebo followed by Indacaterol 300μg | Experimental | In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. Receives: Drug: Indacaterol 300μg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14
Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.
Measured: Day 14
Secondary outcomes (4)
Static Inspiratory Capacity (IC) at Day 14
Inspiratory Capacity (IC) at resting (static IC) was measured by using whole body plethysmography. The day 14 measurement was analyzed using an analysis of variance including baseline (day -2) as a covariate,
Measured: Day 14
Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose. The linear mixed model included the baseline FEV1 measurement as covariate.
Measured: Day 14
Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14
Dyspnoea was measured during the treatment period using the transition dyspnoea index (TDI), which captures changes from baseline. The TDI has three domains; functional impairment, magnitude of task and magnitude of effort. TDI domains are rated from -3 (major deterioration) to 3 (major improvement) and rates are summed for transition focal score ranging from -9 to 9; minus scores indicate deterioration. A TDI focal score of 1 was considered to be a clinically significant and meaningful improvement from baseline. Analysis of variance included period baseline dyspnoea index (BDI) as covariate.
Measured: Day 14
Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14
The modified Borg CR10 Scale consists of 12-point score that the patients point to so as to indicate their level of dyspnoea (where 0 indicates no breathlessness at all to 12 indicates maximum breathlessness), before and during exercise testing. A reduction in this score indicates an improvement. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests. Peak time was defined as the last measurement taken in the exercise period. Analysis of variance included period, treatment and sequence as fixed effects and subject as random effect.
Measured: Day 1, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionAug 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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 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
- NCT00636961
- Sponsor's protocol ID
- CQAB149B2318
- Status last verified
- Jul 2011
- First submitted
- 10 Mar 2008
- Last updated
- 30 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Double Blind, Randomized, Placebo-controlled, 2-way Cross-over Study to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With COPD
- ClinicalTrials.gov ID
- NCT00636961
- Acronym / sponsor ID
- CQAB149B2318
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Indacaterol Maleate, Exercise testing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Posted 30 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Indacaterol 300μg followed by Placebo | Experimental | Drug: Indacaterol 300μg, Drug: PlaceboIn period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
| Sequence 2 : Placebo followed by Indacaterol 300μg | Experimental | Drug: Indacaterol 300μg, Drug: PlaceboIn period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects,
- 40 to 80 years of age,
- with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
- Subjects who demonstrate a plethysmographic functional residual capacity >120% predicted normal
Key exclusion criteria (6 listed)
- No COPD exacerbations within 6 weeks prior to dosing,
- no concomitant lung disease such as asthma,
- no requirement for long term oxygen treatment or history of lung reduction surgery.
- No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
- Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease
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 300μgAlso: Arcapta300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device | Drug | Sequence 1: Indacaterol 300μg followed by Placebo, Sequence 2 : Placebo followed by Indacaterol 300μg |
| PlaceboMatching placebo devices and hard gelatin capsules | Drug | Sequence 1: Indacaterol 300μg followed by Placebo, Sequence 2 : Placebo followed by Indacaterol 300μg |
Primary outcome
Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14
Time frame: Day 14
Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.
4 secondary outcomes
Static Inspiratory Capacity (IC) at Day 14
Time frame: Day 14
Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14
Time frame: Day 14
Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14
Time frame: Day 14
Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14
Time frame: Day 1, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
- 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 300μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 3 sites in Germany.
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 4 inclusion and 6 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 30 Aug 2011. 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 Germany. 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.
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 30 Aug 2011). 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?
Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14 (time frame: Day 14). 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 30 Aug 2011; AzTrials last refreshed its copy on 31 Oct 2026.