Chronic Obstructive Pulmonary DiseasePhase 4INSTEADNCT01555138
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
A Phase 4 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 94 sites in 9 countries.
Trial summary
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate. 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 and Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 participants
- Where
- 94 sitesin 9 countries
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 4
- 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
- Patients with moderate COPD (Stage II)
- Able to perform spirometry assessments
- Current or ex-smokers
- On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.
Who cannot join
- Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
- Having a history of, or current ECG abnormality
- Asthma
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
94 sites in 9 countries.
94 sites in 9 countries
Argentina32 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, 1425
Novartis Investigative Site
Buenos Aires, Buenos Aires, B6500EZL
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1120AAC
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1125ABE
Novartis Investigative Site
Buenos Aires, C1440BRR
Novartis Investigative Site
C A B A, Buenos Aires
Novartis Investigative Site
Caba, Argentina, C1119ACN
Novartis Investigative Site
Caba, Buenos Aires, 1028
Novartis Investigative Site
Caba, Buenos Aires, 1122
Novartis Investigative Site
Caba, Buenos Aires, 1209
Novartis Investigative Site
Caba, Buenos Aires, 1425
Novartis Investigative Site
Caba, Buenos Aires, B8000XAV
Novartis Investigative Site
Caba, Buenos Aires, C1056ABJ
Novartis Investigative Site
Caba, Buenos Aires, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, C1280AEB
Novartis Investigative Site
Caba, Buenos Aires, C1414AIF
Novartis Investigative Site
Caba, Buenos Aires, C1425DQI
Novartis Investigative Site
Concepción del Uruguay, Entre Ríos Province, 3260
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
Novartis Investigative Site
La Plata, Buenos Aires, 1900
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600DHK
Novartis Investigative Site
Mendoza, Mendoza Province, 5500
Novartis Investigative Site
Mendoza, Mendoza Province, M5500CBA
Novartis Investigative Site
Quilmes, Buenos Aires, B1878FNR
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXH
Novartis Investigative Site
Salta, Salta Province, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IFL
Novartis Investigative Site
Santa Fe, Rosario, S2000DBS
Novartis Investigative Site
Santa Fe, Santa Fe Province, S3000FIL
Novartis Investigative Site
Villa María, Córdoba Province, X5900JKA
Italy25 sites
Novartis Investigative Site
Acquaviva delle Fonti, BA, 70021
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Caserta, CE, 81100
Novartis Investigative Site
Cassano delle Murge, BA, 70020
Novartis Investigative Site
Cassino, FR, 03043
Novartis Investigative Site
Cittadella, PD, 35013
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Cuasso al Monte, VA, 21050
Novartis Investigative Site
Foggia, FG, 71100
Novartis Investigative Site
Forlì, FC, 47100
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Messina, ME, 98158
Novartis Investigative Site
Milan, MI, 20123
Novartis Investigative Site
Milan, MI, 20126
Novartis Investigative Site
Milan, MI, 20142
Novartis Investigative Site
Negrar, VR, 37024
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Pordenone, PN, 33170
Novartis Investigative Site
Salerno, SA, 84131
Novartis Investigative Site
Sesto San Giovanni, Mi, 20099
Novartis Investigative Site
Tradate, VA, 21049
Novartis Investigative Site
Treviglio, BG, 24047
Novartis Investigative Site
Verona, VR, 37126
Spain9 sites
Novartis Investigative Site
Barcelona, Catalonia, 08024
Novartis Investigative Site
Canet de Mar, Catalonia, 08360
Novartis Investigative Site
Corbera de Llobregat, Catalonia, 08757
Novartis Investigative Site
Lleida, Catalonia, 25198
Novartis Investigative Site
Loja, Andalusia, 18300
Novartis Investigative Site
Madrid, Madrid, 28029
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Novartis Investigative Site
Valladolid, Castille and León, 47011
United Kingdom9 sites
Novartis Investigative Site
Bradford, BD9 6RJ
Novartis Investigative Site
Chester, CH2 1UL
Novartis Investigative Site
Dundee, Perthshire, DD1 2BU
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
Hants, Southampton, SO9 5NY
Novartis Investigative Site
Kettering, NN16 8UZ
Novartis Investigative Site
Lancaster, LA1 4RP
Novartis Investigative Site
Newcastle upon Tyne, Newcastle-upon-Tyne, NE7 7DN
Novartis Investigative Site
Surrey, KT16 0PZ
Mexico6 sites
Novartis Investigative Site
Guadalajara, Jalisco, 44100
Novartis Investigative Site
Mexico City, Mexico City, 11950
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Monterrey, Nuevo León, 64718
Novartis Investigative Site
Querétaro City, Querétaro, 76000
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78200
Switzerland4 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Biel, 2500
Novartis Investigative Site
Gossau, 9200
Novartis Investigative Site
Muenchenstein, Switzerland, 4241
Colombia3 sites
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogota, Cundinamarca
Novartis Investigative Site
Bogotá
Malaysia3 sites
Novartis Investigative Site
Kuching, Sarawak, 93586
Novartis Investigative Site
Pulau Pinang, 10990
Novartis Investigative Site
Wilayah Persekutuan, Kuala Lumpur, 50590
Netherlands3 sites
Novartis Investigative Site
Breda, Netherlands, 4819 EV
Novartis Investigative Site
Helmond, Netherlands, 5707 HA
Novartis Investigative Site
Rotterdam, 3045 PM
About this study
Official title: A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Indacaterol, Salmeterol
- Keywords
- Chronic Obstructive Pulmonary Disease, Indacaterol, Salmeterol/fluticasone propionate
- 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
Indacaterol is delivered via a SDDPI.
SalmeterolDrug
Salmeterol/fluticasone is delivered via a MDDPI
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) Receives: Drug: Indacaterol |
| Salmeterol/fluticasone propionate | Active comparator | Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.) Receives: Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
Measured: 12 weeks
Secondary outcomes (10)
Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.
Measured: 26 weeks
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Measured: 12 weeks
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .
Measured: 26 weeks
FVC Over 26 Weeks of Treatment
FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Measured: 12 and 26 weeks
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.
Measured: 12 and 26 weeks
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.
Measured: 12 and 26 weeks
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.
Measured: 26 weeks
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.
Measured: 12 and 26 weeks
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'.
Measured: 26 weeks
St Georges Respiratory Questionnaire for COPD
A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
Measured: 12 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555138
- Sponsor's protocol ID
- CQAB149B2401
- Other IDs
- 2011-003732-31
- Acronym
- INSTEAD
- Status last verified
- Apr 2015
- First submitted
- 13 Mar 2012
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01555138
- Acronym / sponsor ID
- INSTEAD / CQAB149B2401
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Indacaterol, Salmeterol/fluticasone propionate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 28 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Drug: IndacaterolIndacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) |
| Salmeterol/fluticasone propionate | Active comparator | Drug: SalmeterolSalmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with moderate COPD (Stage II)
- Able to perform spirometry assessments
- Current or ex-smokers
- On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.
Key exclusion criteria (4 listed)
- Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
- Having a history of, or current ECG abnormality
- Asthma
- 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 |
|---|---|---|
| IndacaterolIndacaterol is delivered via a SDDPI. | Drug | Indacaterol |
| SalmeterolSalmeterol/fluticasone is delivered via a MDDPI | Drug | Salmeterol/fluticasone propionate |
Primary outcome
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
Time frame: 12 weeks
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
10 secondary outcomes
Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
Time frame: 26 weeks
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
Time frame: 12 weeks
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
Time frame: 26 weeks
FVC Over 26 Weeks of Treatment
Time frame: 12 and 26 weeks
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
Time frame: 12 and 26 weeks
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
Time frame: 12 and 26 weeks
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
Time frame: 26 weeks
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Time frame: 12 and 26 weeks
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
Time frame: 26 weeks
St Georges Respiratory Questionnaire for COPD
Time frame: 12 and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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
94 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indacaterol and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis Pharmaceuticals at 94 sites in 9 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 4 inclusion and 4 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in Argentina, Italy, Spain, United Kingdom, Mexico and 4 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 28 Apr 2015). 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?
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons (time frame: 12 weeks). 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 28 Apr 2015.