Chronic Obstructive Pulmonary DiseasePhase 3NCT00669617
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Indacaterol, Salmeterol/fluticasone (50/500 μg) and Salbutamol (200 µg) in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 17 sites in 4 countries.
Trial summary
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Indacaterol, Salmeterol/fluticasone (50/500 μg) and Salbutamol (200 µg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Apr 2008to Aug 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:
- Smoking history of at least 20 pack years
- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) <80% and ≥30% of the predicted normal value.
- Post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 70%, where FVC is forced vital capacity ('Post-' refers to 15-30 minutes after inhalation of 400 μg of salbutamol at Visit 2)
Who cannot join
- Pregnant / nursing women or women of child-bearing potential
- Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia
- Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3
- Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3
- Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
- Any history of asthma, including: blood eosinophil count >400/mm3; onset of asthma symptoms prior to age 40 years
Show all 16Show fewer
- History of long QT syndrome or whose QTc (Bazett's) measured at Visit 2 or Visit 3 is prolonged (>450ms for males or >470ms for females)
- Clinically relevant lab abnormalities / conditions such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigator's opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
- Uncontrolled Type I / Type II Diabetes or blood glucose outside normal or HbA1c >8.0% of total hemoglobin measured at Visit 2
- Any patient with lung cancer or any active cancer or a history of cancer with less than 5 years disease-free survival time
- History of hypersensitivity to any of the study drugs
- Irregular day/night, waking/sleeping cycles e.g. shift workers
- Live attenuated vaccinations within 30 days prior to Visit 2
- Investigational drug within 30 days prior to Visit 2
- Known history of non-compliance or not able to use devices or perform spirometry
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Germany8 sites
Novartis Investigative Site
Berlin
Novartis Investigator Site
Borstel
Novartis Investigative site
Dortmund
Novartis Investigative site
Hamburg
Novartis Investigative site
Hanover
Novartis Investigative site
Mainz
Novartis Investigator Site
Potsdam
Novartis Investigative site
Wiesbaden
United States5 sites
Novartis Investigative Site
Beaver, Pennsylvania, 15009
Novartis Investigator Site
Lafayette, Louisiana, 70503
Novartis Investigative Site
Saint Charles, Missouri, 63301-2847
Novartis Investigative site
Shelby, North Carolina, 28150
Novartis Investigative Site
Tamarac, Florida, 33321
Hungary3 sites
Novartis Investigative site
Debrecen
Novartis Investigative site
Deszk
Novartis Investigative Site
Nyíregyháza
About this study
Official title: A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls
This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol, Salmeterol/fluticasone (50/500 μg), Salbutamol (200 µg), Placebo to Indacaterol, Placebo to Salmeterol/fluticasone
- Keywords
- chronic obstructive pulmonary disease, COPD, indacaterol, adults
- 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.
IndacaterolDrug
Also called Arcapta, Neohaler
Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI)
Salmeterol/fluticasone (50/500 μg)Drug
Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Salbutamol (200 µg)Drug
Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI).
Placebo to IndacaterolDrug
Placebo to indacaterol delivered via SDDPI
Placebo to Salmeterol/fluticasoneDrug
Placebo to salmeterol/fluticasone delivered via MDDPI
Placebo to salbutamolDrug
Placebo to salbutamol delivered via MDDPI
| Study group | Role | What they receive |
|---|---|---|
| Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut | Experimental | Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol |
| Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo | Experimental | Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol |
| Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg | Experimental | Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol |
| Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut | Experimental | Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol |
| Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg | Experimental | Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. Receives: Drug: Indacaterol; Drug: Salmeterol/fluticasone (50/500 μg); Drug: Salbutamol (200 µg); Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol/fluticasone; Drug: Placebo to salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.
Measured: Five Minutes Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startApr 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669617
- Sponsor's protocol ID
- CQAB149B2307
- Other IDs
- EUDRACT: 2007-006189-14
- Status last verified
- Sep 2011
- First submitted
- 28 Apr 2008
- Last updated
- 12 Sep 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 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Triple-dummy, Placebo Controlled, Multicenter, 5-period, Single-dose Complete Block Crossover Study to Determine the Onset of Action of Indacaterol (150 and 300 μg) in Patients With Moderate to Severe COPD Using Salbutamol (200 μg) and Salmeterol/Fluticasone (50/500 μg) as Active Controls
- ClinicalTrials.gov ID
- NCT00669617
- Acronym / sponsor ID
- CQAB149B2307
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, COPD, indacaterol, adults
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Apr 2008 (estimated)
- Results
- Posted 17 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 will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut | Experimental | Drug: Indacaterol, Drug: Salmeterol/fluticasone (50/500 μg), Drug: Salbutamol (200 µg), Drug: Placebo to Indacaterol, Drug: Placebo to Salmeterol/fluticasone, Drug: Placebo to salbutamolParticipants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo | Experimental | Drug: Indacaterol, Drug: Salmeterol/fluticasone (50/500 μg), Drug: Salbutamol (200 µg), Drug: Placebo to Indacaterol, Drug: Placebo to Salmeterol/fluticasone, Drug: Placebo to salbutamolParticipants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo. At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg | Experimental | Drug: Indacaterol, Drug: Salmeterol/fluticasone (50/500 μg), Drug: Salbutamol (200 µg), Drug: Placebo to Indacaterol, Drug: Placebo to Salmeterol/fluticasone, Drug: Placebo to salbutamolParticipants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salmeterol/fluticasone 50/500 μg (Salm/flut), Placebo, Indacaterol 150 μg (Ind 150μg), Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut | Experimental | Drug: Indacaterol, Drug: Salmeterol/fluticasone (50/500 μg), Drug: Salbutamol (200 µg), Drug: Placebo to Indacaterol, Drug: Placebo to Salmeterol/fluticasone, Drug: Placebo to salbutamolParticipants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Salbutamol 200 μg (Salbut), Indacaterol 300 μg (Ind 300μg), Placebo, Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
| Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg | Experimental | Drug: Indacaterol, Drug: Salmeterol/fluticasone (50/500 μg), Drug: Salbutamol (200 µg), Drug: Placebo to Indacaterol, Drug: Placebo to Salmeterol/fluticasone, Drug: Placebo to salbutamolParticipants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Placebo, Salbutamol 200 μg (Salbut), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Indacaterol 150 μg (Ind 150μg). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the GOLD Guidelines, 2006) and:
Key exclusion criteria (16 listed)
- Pregnant / nursing women or women of child-bearing potential
- Long term oxygen therapy (more than 15 hours per day) on a daily basis for chronic hypoxemia
- Patients hospitalized for COPD exacerbation in 6 weeks prior to Visit 2 and up to Visit 3
- Respiratory tract infection within 6 weeks prior to Visit 2 and up to Visit 3
- Concomitant pulmonary disease, pulmonary tuberculosis (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
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 |
|---|---|---|
| IndacaterolAlso: Arcapta, NeohalerIndacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI) | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
| Salmeterol/fluticasone (50/500 μg)Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI). | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
| Salbutamol (200 µg)Salbutamol 200 μg delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI). | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
| Placebo to IndacaterolPlacebo to indacaterol delivered via SDDPI | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
| Placebo to Salmeterol/fluticasonePlacebo to salmeterol/fluticasone delivered via MDDPI | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
| Placebo to salbutamolPlacebo to salbutamol delivered via MDDPI | Drug | Ind 150μg, Salm/flut, Ind 300μg, Placebo, Salbut, Ind 300μg, Ind 150μg, Salbut, Salm/flut, Placebo, Placebo, Salbut, Salm/flut , Ind 300μg, Ind 150μg, Salbut, Ind 300μg, Placebo, Ind 150μg, Salm/flut, Salm/flut, Placebo, Ind 150μg, Salbut, Ind 300μg |
Primary outcome
Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose
Time frame: Five Minutes Post Dose
FEV1 was measured at 5 minutes after dosing with spirometry conducted according to internationally accepted standards. The time of dosing was defined as the time corresponding to the use of the first inhaler device. The primary variable was analyzed using a mixed model containing the period baseline FEV1 as covariate. The period baseline FEV1 was the average of the FEV1 value measured in the clinic at 50 and 15 min prior to the study drug administration in that period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol, Salmeterol/fluticasone (50/500 μg) and Salbutamol (200 µg) in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 17 sites in 4 countries.
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 16 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, United States, Hungary, Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 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?
Forced Expiratory Volume in 1 Second (FEV1) at 5 Minutes Post-dose (time frame: Five Minutes Post Dose). 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 12 Sep 2011.