AsthmaPhase 2NCT00818454

4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma

A Phase 2 study testing Combivent CFC MDI, Albuterol HFA MDI and Respimat Combivent in people with Asthma, run by Boehringer Ingelheim at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Combivent CFC MDI, Albuterol HFA MDI and Respimat Combivent
How many people: 226 participants
Where: 41 sitesUnited States
Study dates: Dec 2008to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients must sign and date an Informed Consent consistent with International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines and local regulations prior to participation in the trial (i.e., prior to any study procedures, including washout of any medication) at Visit 1.
Male or female patients greater to or equal to 18 years of age.
Physician diagnosis of moderate-to-severe asthma (GINA Guidelines) existing for >1 year.
Reversible airway obstruction (more than or equal to 12 % or at least 200 mL improvement in FEV1 post bronchodilator after 4 puffs of albuterol HFA MDI).
Pre-bronchodilator clinic measured FEV1 ≤80% of predicted normal value (measured greater to or equal to 6 hours of the last use of short acting bronchodilator and greater to or equal to 12 hours after the last use of LABA if applicable).
Continuous treatment with inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA) and other controller medication(s) for at least 6 weeks prior to screening (GINA 2007 Treatment Steps 3 to 5).

Show all 12Show fewer

No change in dos or regimen of ICS and LABA or other controller medications (including oral corticosteroids [OCS] if applicable), for at least 2 weeks prior to Visit 2.
Use of short acting bronchodilator at least three times a week for symptom relief in the 2 weeks prior to Visit 1.
Score of ≥1.5 points on the Asthma Control Questionnaire (ACQ) (see Appendix 10.6).
Able to perform technically acceptable pulmonary function tests at the clinic and peak flow measurements with the eDiary/Peak Expiratory Flow Meter.
Able to perform all necessary recordings (symptoms and as needed medication use) in the electronic diary, which is a part of the eDiary/Peak Expiratory Flow Meter.
Investigator assessment of patients ability to inhale medication from a metered dose inhaler and RESPIMAT inhaler.

Who cannot join

Significant disease other than asthma not limited to diagnosis of COPD, such as, active tuberculosis, cystic fibrosis, alpha 1 antitrypsin deficiency, clinically significant bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis, or constrictive bronchiolitis. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, or (ii) influence the results of the study, or (iii) cause concern regarding the patient ability to participate in the study.
History of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion 1.
History of life-threatening asthma attack.
Worsening of asthma that required treatment with an addition or increase in OCS dose (steroid burst) in the 4- week period prior to Visit 2.
Current or ex-smokers who quit <1 year before enrollment. Ex-smokers who quit less than 1 year from enrollment must have a cigarette smoking history of less than 10 pack years.
Pack years = Number of cigarettes/day x years of smoking 20

Show all 23Show fewer

Use of oral beta-adrenergic agents within 4 weeks prior to screening.
Treatment with inhaled ipratropium, ipratropium/albuterol combination, or nasal ipratropium within 1week of Visit 2.
Treatment with inhaled tiotropium within 4 weeks of Visit 2.
Known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetracetic acid (EDTA) or any other components of the tiotropium inhalation solution or MDI.
Known narrow-angle glaucoma.
Clinically relevant abnormal hematology or blood chemistry at screening if the abnormality defines a significant disease as defined in exclusion criterion 1.
Recent history (i.e., one year less) of myocardial infarction. Cardiac arrhythmias, newly diagnosed arrhythmias and/or any arrhythmia requiring an intervention (i.e., hospitalization, cardio version, pacemaker placement, and automatic implantable cardiac defibrillator placement) or a change in drug therapy during the last year.
Hospitalization for cardiac failure during the past year.
Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years, with the exception of treated basal cell carcinoma.
Unwillingness or inability to use a highly effective method of birth control by women of childbearing potential. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. Barrier methods of contraception are accepted if condom or occlusive cap is used together with spermicides (e.g., foam or gel). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
Pregnancy or nursing.
Any investigational drug taken within 30 days or six half-lives (whichever is greater) prior to Visit 2.
Previous randomization in this study or current participation in another study.
Symptomatic prostate hypertrophy or bladder neck obstruction. Patients with symptomatically controlled prostate hypertrophy on medications may be included and should continue their medications.
Use of monoamine oxidase inhibitors or tricyclic antidepressants. Examples include but are not limited to the following for monoamine oxidase inhibitors nardil, parnate, marplan and for tricyclic antidepressants: amitriptyline, norpramine, and pamelor.
History of and/or active alcohol or drug abuse.
Patient who have been treated with beta-blocker medication during the screening of the study. Topical cardio-selective beta-blocker eye medications for treatment of acute angle glaucoma are allowed.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

1012.57.104 Boehringer Ingelheim Investigational Site
Augusta, Georgia
1012.57.143 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1012.57.121 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1012.57.146 Boehringer Ingelheim Investigational Site
Bozeman, Montana
1012.57.134 Boehringer Ingelheim Investigational Site
Centennial, Colorado
1012.57.109 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
1012.57.102 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
1012.57.107 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
1012.57.142 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1012.57.136 Boehringer Ingelheim Investigational Site
El Paso, Texas
1012.57.117 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1012.57.108 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania
1012.57.148 Boehringer Ingelheim Investigational Site
Killeen, Texas
1012.57.129 Boehringer Ingelheim Investigational Site
Lake Oswego, Oregon
1012.57.144 Boehringer Ingelheim Investigational Site
Los Angeles, California
1012.57.145 Boehringer Ingelheim Investigational Site
Los Angeles, California
1012.57.140 Boehringer Ingelheim Investigational Site
Louisville, Kentucky
1012.57.105 Boehringer Ingelheim Investigational Site
Madison, Wisconsin
1012.57.113 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1012.57.127 Boehringer Ingelheim Investigational Site
Normal, Illinois
1012.57.126 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1012.57.147 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1012.57.132 Boehringer Ingelheim Investigational Site
Omaha, Nebraska
1012.57.124 Boehringer Ingelheim Investigational Site
Palmdale, California
1012.57.119 Boehringer Ingelheim Investigational Site
Panama City, Florida
1012.57.114 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1012.57.131 Boehringer Ingelheim Investigational Site
Plymouth, Minnesota
1012.57.138 Boehringer Ingelheim Investigational Site
Portland, Oregon
1012.57.118 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1012.57.101 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1012.57.137 Boehringer Ingelheim Investigational Site
San Diego, California
1012.57.141 Boehringer Ingelheim Investigational Site
Seattle, Washington
1012.57.139 Boehringer Ingelheim Investigational Site
Skillman, New Jersey
1012.57.116 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1012.57.130 Boehringer Ingelheim Investigational Site
Stockton, California
1012.57.150 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1012.57.103 Boehringer Ingelheim Investigational Site
Union, South Carolina
1012.57.111 Boehringer Ingelheim Investigational Site
Upland, Pennsylvania
1012.57.151 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
1012.57.128 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
1012.57.149 Boehringer Ingelheim Investigational Site
Winter Park, Florida

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About this study

Official title: A Multicenter Randomized Study Starting With a 4 Week 2 Way Crossover Double Blind Treatment Phase Comparing the Efficacy and Safety of Combivent CFC MDI to Albuterol HFA MDI Followed by a 4 Week Open Label Combivent Respimat Treatment Phase When All Study Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma (GINA 2007 Treatment Steps 3-5)

The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.

Conditions: Asthma
Being tested: Combivent CFC MDI, Albuterol HFA MDI, Respimat Combivent
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combivent CFC MDIDrug
Albuterol HFA MDIDrug
Respimat CombiventDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1 AUC0-6 Response (Crossover Part of the Study)
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.
Measured: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Peak FEV1 Response (Crossover Part of the Study)
Change from baseline after 4 weeks in peak Forced Expiratory Volume response
Measured: Test day baseline and test day peak FEV1, after 4 weeks

Secondary outcomes (8)

Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)
Change from baseline after 4 weeks in Mini-AQLQ score. Worst score - 1 (most severe), best score - 7 (less severe)
Measured: Baseline, 4 weeks
Asthma Control Questionnaire (Crossover Part of the Study)
Change from baseline after 4 weeks in ACQ score. Worst score - 6(most severe), best score - 0 (no symptoms)
Measured: Baseline, 4 weeks
Puffs Study Medication Used During Day (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during day
Measured: Baseline, 4 weeks
Puffs Study Medication Used During Night (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of blinded study medication (albuterol HFA or combivent CFC) used during night
Measured: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of open-label albuterol used during day
Measured: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)
Change from baseline in weekly mean of puffs of open-label albuterol used during night
Measured: Baseline, 4 weeks
FEV1 AUC0-6 Response (Parallel Part of the Study)
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under the Curve from 0 to 6 hours
Measured: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Peak FEV1 Response
Change from baseline after 4 weeks in peak Forced Expiratory Volume response
Measured: Test day baseline and test day peak FEV1, after 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008Sep 2009

First posted7 Jan 2009 (estimated)
Study startDec 2008
Primary completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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
Intervention model: Crossover
Enrolment: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00818454
Sponsor's protocol ID: 1012.57
Other IDs: 57948
Status last verified: Jan 2014
First submitted: 6 Jan 2009
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Donohue JF, Wise R, Busse WW, Garfinkel S, Zubek VB, Ghafouri M, Manuel RC, Schlenker-Herceg R, Bleecker ER. Efficacy and safety of ipratropium bromide/albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial. BMC Pulm Med. 2016 Apr 30;16(1):65. doi: 10.1186/s12890-016-0223-3.
PubMed 27130202

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter Randomized Study Starting With a 4 Week 2 Way Crossover Double Blind Treatment Phase Comparing the Efficacy and Safety of Combivent CFC MDI to Albuterol HFA MDI Followed by a 4 Week Open Label Combivent Respimat Treatment Phase When All Study Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma (GINA 2007 Treatment Steps 3-5)
ClinicalTrials.gov ID: NCT00818454
Acronym / sponsor ID: 1012.57
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Sep 2009 (actual)
First posted: 7 Jan 2009 (estimated)
Results: Posted 23 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Intervention model: Crossover

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

All patients must sign and date an Informed Consent consistent with International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines and local regulations prior to participation in the trial (i.e., prior to any study procedures, including washout of any medication) at Visit 1.
Male or female patients greater to or equal to 18 years of age.
Physician diagnosis of moderate-to-severe asthma (GINA Guidelines) existing for >1 year.
Reversible airway obstruction (more than or equal to 12 % or at least 200 mL improvement in FEV1 post bronchodilator after 4 puffs of albuterol HFA MDI).
Pre-bronchodilator clinic measured FEV1 ≤80% of predicted normal value (measured greater to or equal to 6 hours of the last use of short acting bronchodilator and greater to or equal to 12 hours after the last use of LABA if applicable).

Key exclusion criteria (23 listed)

Significant disease other than asthma not limited to diagnosis of COPD, such as, active tuberculosis, cystic fibrosis, alpha 1 antitrypsin deficiency, clinically significant bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis, or constrictive bronchiolitis. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, or (ii) influence the results of the study, or (iii) cause concern regarding the patient ability to participate in the study.
History of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion 1.
History of life-threatening asthma attack.
Worsening of asthma that required treatment with an addition or increase in OCS dose (steroid burst) in the 4- week period prior to Visit 2.
Current or ex-smokers who quit <1 year before enrollment. Ex-smokers who quit less than 1 year from enrollment must have a cigarette smoking history of less than 10 pack years.

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
Combivent CFC MDI	Drug	–
Albuterol HFA MDI	Drug	–
Respimat Combivent	Drug	–

Primary outcome

FEV1 AUC0-6 Response (Crossover Part of the Study)
Time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Change from baseline after 4 weeks in Forced Expiratory Volume Area Under (FEV1 AUC) the Curve from 0 to 6 hours.
Peak FEV1 Response (Crossover Part of the Study)
Time frame: Test day baseline and test day peak FEV1, after 4 weeks
Change from baseline after 4 weeks in peak Forced Expiratory Volume response

8 secondary outcomes

Mini Asthma Quality of Life Questionnaire (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
Asthma Control Questionnaire (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
Puffs Study Medication Used During Day (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
Puffs Study Medication Used During Night (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Day (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
Puffs Open-label Albuterol Used During Night (Crossover Part of the Study)
Time frame: Baseline, 4 weeks
FEV1 AUC0-6 Response (Parallel Part of the Study)
Time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks
Peak FEV1 Response
Time frame: Test day baseline and test day peak FEV1, after 4 weeks

Results and safety

Results posted to the registry on 23 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Albuterol HFA First, Then Combivent CFC	115	112
Combivent CFC First, Then Albuterol HFA	111	110
Placebo Respimat	0	0
Combivent Respimat	0	0

Primary outcome: FEV1 AUC0-6 Response (Crossover Part of the Study)

Time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks. Least squares mean (Standard Error). Unit: liters

Measure	Albuterol HFA n = 191	Combivent CFC n = 193
Value	0.167 (0.026)	0.252 (0.026)

Albuterol HFA vs Combivent CFC: p <0.0001, MMRM ANCOVA

Population analysed: Full analysis set 1 (FAS1) consisted of all patients who were dispensed study medication, were documented to have taken at least one dose of investigational treatment, and had non-missing Visit 3 baseline values and non-missing responses for both peak FEV1 and FEV1 AUC0-6 at Visit 3.

Primary outcome: Peak FEV1 Response (Crossover Part of the Study)

Time frame: Test day baseline and test day peak FEV1, after 4 weeks. Least squares mean (Standard Error). Unit: liters

Measure	Albuterol HFA n = 191	Combivent CFC n = 193
Value	0.357 (0.031)	0.434 (0.031)

Albuterol HFA vs Combivent CFC: p <0.0001, MMRM ANCOVA

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 days (Treatment phase 1) + 29 days (Treatment phase 2) + 29 days (Treatment phase 3). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albuterol HFA First, Then Combivent CFC	1 of 222 (0.5%)	1 of 222 (0.5%)	Not reported
Combivent CFC First, Then Albuterol HFA	1 of 219 (0.5%)	11 of 219 (5%)	Not reported
Placebo Respimat	0 of 26 (0%)	0 of 26 (0%)	Not reported
Combivent Respimat	0 of 139 (0%)	0 of 139 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27130202Donohue JF, Wise R, Busse WW, Garfinkel S, Zubek VB, Ghafouri M, Manuel RC, Schlenker-Herceg R, Bleecker ER. Efficacy and safety of ipratropium bromide/albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial. BMC Pulm Med. 2016 Apr 30;16(1):65. doi: 10.1186/s12890-016-0223-3.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combivent CFC MDI, Albuterol HFA MDI and Respimat Combivent in people with Asthma, run by Boehringer Ingelheim at 41 sites in United States.

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 12 inclusion and 23 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. 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 23 Nov 2010). 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?

FEV1 AUC0-6 Response (Crossover Part of the Study) (time frame: Test day baseline and test day FEV1 AUC 0-6, after 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00818454, which also lists 1 linked publication.

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 14 Feb 2014.