AsthmaPhase 2NCT01484197
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
A Phase 2 study testing 75 µg indacaterol maleate (LB), 75 µg indacaterol maleate (PoS) and 37.5 µg indacaterol maleate (PoS) in people with Asthma, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- 75 µg indacaterol maleate (LB), 75 µg indacaterol maleate (PoS) and 37.5 µg indacaterol maleate (PoS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to May 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients with asthma
- Aged 18 or above
- Patients using inhaled corticosteroid (with or without long acting beta agonist)
- Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist
Who cannot join
- Asthma exacerbations in previous 6 months
- COPD or other pulmonary disease
- Excessive use of short acting beta agonists
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
- Conditions
- Asthma
- Being tested
- 75 µg indacaterol maleate (LB), 75 µg indacaterol maleate (PoS), 37.5 µg indacaterol maleate (PoS), placebo to indacaterol (LB), placebo to indacaterol (PoS)
- Keywords
- Asthma, Indacaterol, QAB149
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75 µg indacaterol maleate (LB)Drug
75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
75 µg indacaterol maleate (PoS)Drug
75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
37.5 µg indacaterol maleate (PoS)Drug
37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
placebo to indacaterol (LB)Drug
Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
placebo to indacaterol (PoS)Drug
Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 75 µg Indacaterol (LB) + Placebo (PoS) | Experimental | 75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. Receives: Drug: 75 µg indacaterol maleate (LB); Drug: placebo to indacaterol (PoS) |
| 75 µg Indacaterol (PoS) + Placebo (LB) | Experimental | 75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. Receives: Drug: 75 µg indacaterol maleate (PoS); Drug: placebo to indacaterol (LB) |
| 37.5 µg Indacaterol (PoS) + Placebo (LB) | Experimental | 37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. Receives: Drug: 37.5 µg indacaterol maleate (PoS); Drug: placebo to indacaterol (LB) |
| Placebo (LB) and Placebo (PoS) | Experimental | Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. Receives: Drug: placebo to indacaterol (LB); Drug: placebo to indacaterol (PoS) |
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) After 7 Days of Treatment
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Measured: Day 8
Secondary outcomes (19)
Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Measured: Day 2
Peak FEV1 at Day 1 and Day 7
Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.
Measured: Day 1, Day 7
Time to Peak FEV1 at Day 1 and Day 7
Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Measured: Day 1, Day 7
FEV1 at Each Time-Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Day 1, Day 2
FEV1 at Each Time-Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Day 7, Day 8
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Day 1, Day 2
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Day 7, Day 8
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Measured: Day1, Day 2
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.
Measured: Day 7, Day 8
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Measured: Day 1, Day 2
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
Measured: Day 7, Day 8
Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Measured: Day 1, Day 7
Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.
Measured: Day 1, Day 7
Peak Expiratory Flow Rate in the Morning in the Evening
PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.
Measured: Up to 101 days
Number of Puffs of Rescue Medicine
Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.
Measured: Up to 101 days
Number of Participants With Adverse Events as a Measure of Safety
Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section
Measured: Up to 101 days
Time to Reach Maximum Concentration (Tmax) After Drug Administration
Measured: Day1, Day 7
Observed Maximum Concentration (Cmax) After Drug Administration
Measured: Day 1, Day 7
Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
Measured: Day 1, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT01484197
- Sponsor's protocol ID
- CIDD001A2201
- Other IDs
- 2011-001825-25
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2011
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma
- ClinicalTrials.gov ID
- NCT01484197
- Acronym / sponsor ID
- CIDD001A2201
- Conditions
- Asthma
- Keywords
- Asthma, Indacaterol, QAB149
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Posted 6 Dec 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 assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 75 µg Indacaterol (LB) + Placebo (PoS) | Experimental | Drug: 75 µg indacaterol maleate (LB), Drug: placebo to indacaterol (PoS)75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. |
| 75 µg Indacaterol (PoS) + Placebo (LB) | Experimental | Drug: 75 µg indacaterol maleate (PoS), Drug: placebo to indacaterol (LB)75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| 37.5 µg Indacaterol (PoS) + Placebo (LB) | Experimental | Drug: 37.5 µg indacaterol maleate (PoS), Drug: placebo to indacaterol (LB)37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
| Placebo (LB) and Placebo (PoS) | Experimental | Drug: placebo to indacaterol (LB), Drug: placebo to indacaterol (PoS)Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients with asthma
- Aged 18 or above
- Patients using inhaled corticosteroid (with or without long acting beta agonist)
- Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist
Key exclusion criteria (3 listed)
- Asthma exacerbations in previous 6 months
- COPD or other pulmonary disease
- Excessive use of short acting beta agonists
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 |
|---|---|---|
| 75 µg indacaterol maleate (LB)75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. | Drug | 75 µg Indacaterol (LB) + Placebo (PoS) |
| 75 µg indacaterol maleate (PoS)75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. | Drug | 75 µg Indacaterol (PoS) + Placebo (LB) |
| 37.5 µg indacaterol maleate (PoS)37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. | Drug | 37.5 µg Indacaterol (PoS) + Placebo (LB) |
| placebo to indacaterol (LB)Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days. | Drug | 37.5 µg Indacaterol (PoS) + Placebo (LB), 75 µg Indacaterol (PoS) + Placebo (LB), Placebo (LB) and Placebo (PoS) |
| placebo to indacaterol (PoS)Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days. | Drug | 75 µg Indacaterol (LB) + Placebo (PoS), Placebo (LB) and Placebo (PoS) |
Primary outcome
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
Time frame: Day 8
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
19 secondary outcomes
Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment
Time frame: Day 2
Peak FEV1 at Day 1 and Day 7
Time frame: Day 1, Day 7
Time to Peak FEV1 at Day 1 and Day 7
Time frame: Day 1, Day 7
FEV1 at Each Time-Point on Day 1 and Day 2
Time frame: Day 1, Day 2
FEV1 at Each Time-Point on Day 7 and Day 8
Time frame: Day 7, Day 8
Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2
Time frame: Day 1, Day 2
Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8
Time frame: Day 7, Day 8
FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2
Time frame: Day1, Day 2
FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8
Time frame: Day 7, Day 8
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2
Time frame: Day 1, Day 2
Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8
Time frame: Day 7, Day 8
Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)
Time frame: Day 1, Day 7
Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)
Time frame: Day 1, Day 7
Peak Expiratory Flow Rate in the Morning in the Evening
Time frame: Up to 101 days
Number of Puffs of Rescue Medicine
Time frame: Up to 101 days
Number of Participants With Adverse Events as a Measure of Safety
Time frame: Up to 101 days
Time to Reach Maximum Concentration (Tmax) After Drug Administration
Time frame: Day1, Day 7
Observed Maximum Concentration (Cmax) After Drug Administration
Time frame: Day 1, Day 7
Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)
Time frame: Day 1, Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- 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 Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 75 µg indacaterol maleate (LB), 75 µg indacaterol maleate (PoS) and 37.5 µg indacaterol maleate (PoS) in people with Asthma, run by Novartis Pharmaceuticals at 2 sites in 2 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 3 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 1 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 2 sites in Germany, United Kingdom. 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 6 Dec 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?
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment (time frame: Day 8). 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 1 Apr 2015.