AsthmaPhase 2NCT00927901
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Salts in Patients With Asthma
A Phase 2 study testing Indacaterol maleate 400 μg, Indacaterol acetate 400 μg and Indacaterol xinafoate 400 μg in people with Asthma, run by Novartis Pharmaceuticals at 3 sites in 3 countries.
Trial summary
This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Indacaterol maleate 400 μg, Indacaterol acetate 400 μg and Indacaterol xinafoate 400 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2009to Nov 2009
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
- Patients with asthma, receiving daily treatment with inhaled corticosteroid.
- Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range 18-32 kg/m^2 (inclusive).
- Able to communicate well with the investigator and comply with the requirements of the study.
Who cannot join
- A urine cotinine level greater than the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
- Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening.
- Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
- Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
- Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler [MDI] or equivalent dose of a dry-powder inhaler [DPI]) on any 2 consecutive days from screening to randomization.
- Patients diagnosed with chronic obstructive pulmonary disease (COPD) as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (2008).
Show all 15Show fewer
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. Previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study.
- Significant illness.
- History of being immunocompromised, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot).
- A positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
- Patients who are considered vulnerable as per ICH GCP guidelines.
- Patients with a history of hypersensitivity to indacaterol or to similar drugs including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- Treatments for asthma and allied conditions:
- The following treatments should not be used unless they have been stabilized prior to screening: antihistamines, inhaled nasal cromolyn, inhaled nasal corticosteroids, and maintenance immunotherapy.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma
This study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.
- Conditions
- Asthma
- Being tested
- Indacaterol maleate 400 μg, Indacaterol acetate 400 μg, Indacaterol xinafoate 400 μg, Placebo to indacaterol
- Keywords
- QAB149, asthma, indacaterol salts (acetate, maleate, and xinafoate), orally inhaled indacaterol salts, persistent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol maleate 400 μgDrug
Indacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
Indacaterol acetate 400 μgDrug
Indacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
Indacaterol xinafoate 400 μgDrug
Indacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol.
Placebo to indacaterolDrug
Placebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate | Experimental | In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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 maleate 400 μg; Drug: Indacaterol acetate 400 μg; Drug: Indacaterol xinafoate 400 μg; Drug: Placebo to indacaterol |
| Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo | Experimental | In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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 maleate 400 μg; Drug: Indacaterol acetate 400 μg; Drug: Indacaterol xinafoate 400 μg; Drug: Placebo to indacaterol |
| Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate | Experimental | In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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 maleate 400 μg; Drug: Indacaterol acetate 400 μg; Drug: Indacaterol xinafoate 400 μg; Drug: Placebo to indacaterol |
| Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate | Experimental | In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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 maleate 400 μg; Drug: Indacaterol acetate 400 μg; Drug: Indacaterol xinafoate 400 μg; Drug: Placebo to indacaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
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 at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
Measured: Baseline to the end of each treatment period (Day 7)
Secondary outcomes (5)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
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 at Baseline and on Day 1. The analysis included period baseline FEV1 as covariate.
Measured: Baseline to Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 2, 4, and 12 hours post-dose on Day 1 and Day 7.
Measured: Day 1 and Day 7
Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
Patients recorded use of rescue medication (salbutamol/albuterol multi-dose inhaler) as the number of puffs taken in respective preceding 12 hours morning and evening in a diary. Patient with any use of rescue medication (any number of puffs > 0) was included to calculate endpoint.
Measured: Baseline to the end of each treatment period (Day 7)
Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC[0-24 hours]) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Measured: End of each treatment period (Day 7)
Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
Venous blood samples for pharmacokinetic evaluation were collected at 15 and 30 minutes; and 1, 2, 4, 12, and 24 hours post-dose at the end of each 7 day treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data and recorded sampling times using non-compartmental methods.
Measured: End of each treatment period (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT00927901
- Sponsor's protocol ID
- CQAB149D2301
- Other IDs
- 2009-010589-46, 2009
- Status last verified
- Aug 2013
- First submitted
- 24 Jun 2009
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Double-blind, Placebo-controlled, Multiple-dose, 4-way Crossover Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Orally Inhaled Indacaterol Salts (Maleate, Xinafoate, and Acetate) in Patients With Persistent Asthma
- ClinicalTrials.gov ID
- NCT00927901
- Acronym / sponsor ID
- CQAB149D2301
- Conditions
- Asthma
- Keywords
- QAB149, asthma, indacaterol salts (acetate, maleate, and xinafoate), orally inhaled indacaterol salts, persistent asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 25 Jun 2009 (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 assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate | Experimental | Drug: Indacaterol maleate 400 μg, Drug: Indacaterol acetate 400 μg, Drug: Indacaterol xinafoate 400 μg, Drug: Placebo to indacaterolIn treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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. |
| Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo | Experimental | Drug: Indacaterol maleate 400 μg, Drug: Indacaterol acetate 400 μg, Drug: Indacaterol xinafoate 400 μg, Drug: Placebo to indacaterolIn treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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. |
| Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate | Experimental | Drug: Indacaterol maleate 400 μg, Drug: Indacaterol acetate 400 μg, Drug: Indacaterol xinafoate 400 μg, Drug: Placebo to indacaterolIn treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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-indacaterol (ind) acetate-ind maleate-ind xinafoate | Experimental | Drug: Indacaterol maleate 400 μg, Drug: Indacaterol acetate 400 μg, Drug: Indacaterol xinafoate 400 μg, Drug: Placebo to indacaterolIn treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment once daily for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. 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
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening.
- Patients with asthma, receiving daily treatment with inhaled corticosteroid.
- Patients with a forced expiratory volume in 1 second (FEV1) during screening of ≥ 50% of the predicted normal value for the patient.
- Body mass index (BMI) must be within the range 18-32 kg/m^2 (inclusive).
- Able to communicate well with the investigator and comply with the requirements of the study.
Key exclusion criteria (15 listed)
- A urine cotinine level greater than the local laboratory lowest level of quantification (LOQ of 500 ng/ml or lower).
- Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening.
- Patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
- Patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study.
- Patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler [MDI] or equivalent dose of a dry-powder inhaler [DPI]) on any 2 consecutive days from screening to randomization.
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 maleate 400 μgIndacaterol maleate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. | Drug | Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate, Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate, Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo, Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate |
| Indacaterol acetate 400 μgIndacaterol acetate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. | Drug | Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate, Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate, Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo, Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate |
| Indacaterol xinafoate 400 μgIndacaterol xinafoate 400 μg was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. | Drug | Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate, Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate, Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo, Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate |
| Placebo to indacaterolPlacebo to indacaterol was provided in powder filled capsules with the Concept1 single-dose dry-powder inhaler. | Drug | Indacaterol (ind) acetate-ind xinafoate-placebo-ind maleate, Indacaterol (ind) maleate-placebo-ind xinafoate-ind acetate, Indacaterol (ind) xinafoate-ind maleate-ind acetate-placebo, Placebo-indacaterol (ind) acetate-ind maleate-ind xinafoate |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7)
Time frame: Baseline to the end of each treatment period (Day 7)
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 at Baseline and at the end of each treatment period. The analysis included period baseline FEV1 as covariate.
5 secondary outcomes
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 1
Time frame: Baseline to Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 7
Time frame: Day 1 and Day 7
Percentage of Patients Using Rescue Medication During Each 7 Day Treatment Period
Time frame: Baseline to the end of each treatment period (Day 7)
Indacaterol Exposure (AUC[0-24 Hours]) at the End of Each 7 Day Treatment Period
Time frame: End of each treatment period (Day 7)
Indacaterol Exposure (Cmax) at the End of Each 7 Day Treatment Period
Time frame: End of each treatment period (Day 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indacaterol maleate 400 μg, Indacaterol acetate 400 μg and Indacaterol xinafoate 400 μg in people with Asthma, run by Novartis Pharmaceuticals at 3 sites in 3 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 15 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 9 Sep 2013. 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 France, Germany, Italy. 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?
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Each Treatment Period (Day 7) (time frame: Baseline to the end of each treatment period (Day 7)). 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 9 Sep 2013.