A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

NCT01479621 | Completed Phase 2 Results

• 2 other identifiers: FpS-AS-2012010-023600-27
• Study Type: interventional
• Target: 909
• Locations: 9 countries
• Sites: 189

Brief Summary

This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.

Conditions

Asthma

Keywords

Dose Ranging; Fluticasone Propionate; Dry Powder Inhaler (DPI); Non-steroidal; Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period

  Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment\*visit with an unstructured covariance matrix assumed.

  Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

Secondary Outcomes (9)

• Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period

  Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

• Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period

  Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

• Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period

  Baseline (Days -7 to -1), During Study (Days 1-84)

• Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12

  Day 1 to Day 84

• Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp

  Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose

Other Outcomes (3)

• Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data

  Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)

• Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data

  Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

• Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data

  Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

Study Arms (6)

Fp MDPI 12.5 mcg

EXPERIMENTAL

Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 25 mcg

EXPERIMENTAL

Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 50 mcg

EXPERIMENTAL

Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Fp MDPI 100 mcg

EXPERIMENTAL

Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: Fp MDPI; Drug: albuterol/salbutamol

Placebo MDPI

EXPERIMENTAL

Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: albuterol/salbutamol; Drug: Placebo MDPI

Flovent Diskus 100mcg

EXPERIMENTAL

Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Drug: Flovent Diskus; Drug: albuterol/salbutamol

Interventions

Fp MDPI DRUG

Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening

Also known as: Fluticasone propionate, Fp SPIROMAX® Inhalation Powder

Fp MDPI 100 mcg; Fp MDPI 12.5 mcg; Fp MDPI 25 mcg; Fp MDPI 50 mcg

Flovent Diskus DRUG

Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.

Also known as: Fluticasone propionate

Flovent Diskus 100mcg

albuterol/salbutamol DRUG

A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Also known as: short-acting β2-adrenergic agonists

Flovent Diskus 100mcg; Fp MDPI 100 mcg; Fp MDPI 12.5 mcg; Fp MDPI 25 mcg; Fp MDPI 50 mcg; Placebo MDPI

Placebo MDPI DRUG

Placebo multidose dry powder inhaler in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.

Placebo MDPI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
• Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
• General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
• Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
• Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects.
• Reversibility of Disease: Demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen.
• Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.
• Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
• Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
• If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of
• Non-childbearing potential, defined as:
• Before menarche or \> or =1 year post-menopausal or
• Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or
• Congenital sterility or
• Diagnosed as infertile and not undergoing treatment to reverse infertility or is of

You may not qualify if:

• History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
• Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
• Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit.
• Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular non-corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular non-corticosteroid maintenance treatment, or the addition of other asthma medications.
• Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
• Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
• Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:
• Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit)
• Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP \>100)
• Stroke within 3 months prior to the Screening Visit
• Immunologic compromise
• History of a positive test for HIV, hepatitis B or hepatitis C infection.
• Clinical visual evidence of oral candidiasis at the Screening Visit.
• History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
• History of severe allergy to milk protein.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (189)

Teva Investigational Site 10165

Homewood, Alabama, United States

Location

Teva Investigational Site 11142

Goodyear, Arizona, United States

Location

Teva Investigational Site 10104

Scottsdale, Arizona, United States

Location

Teva Investigational Site 11149

Little Rock, Arkansas, United States

Location

Teva Investigational Site 10173

Bakersfield, California, United States

Location

Teva Investigational Site 10163

Costa Mesa, California, United States

Location

Teva Investigational Site 10156

Encinitas, California, United States

Location

Teva Investigational Site 11101

Fountain Valley, California, United States

Location

Teva Investigational Site 11111

Fresno, California, United States

Location

Teva Investigational Site 10151

Granada Hills, California, United States

Location

Teva Investigational Site 10157

Huntington Beach, California, United States

Location

Teva Investigational Site 10176

Huntington Beach, California, United States

Location

Teva Investigational Site 10147

Long Beach, California, United States

Location

Teva Investigational Site 11110

Napa, California, United States

Location

Teva Investigational Site 10136

Newport Beach, California, United States

Location

Teva Investigational Site 11122

North Hollywood, California, United States

Location

Teva Investigational Site 10140

Orange, California, United States

Location

Teva Investigational Site 10197

Palmdale, California, United States

Location

Teva Investigational Site 10185

Redwood City, California, United States

Location

Teva Investigational Site 10143

Riverside, California, United States

Location

Teva Investigational Site 11137

Roseville, California, United States

Location

Teva Investigational Site 10130

San Diego, California, United States

Location

Teva Investigational Site 10182

San Diego, California, United States

Location

Teva Investigational Site 10179

San Jose, California, United States

Location

Teva Investigational Site 10106

Stockton, California, United States

Location

Teva Investigational Site 10129

Walnut Creek, California, United States

Location

Teva Investigational Site 10145

Centennial, Colorado, United States

Location

Teva Investigational Site 10172

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10133

Denver, Colorado, United States

Location

Teva Investigational Site 10154

Denver, Colorado, United States

Location

Teva Investigational Site 11146

Denver, Colorado, United States

Location

Teva Investigational Site 10128

Wheat Ridge, Colorado, United States

Location

Teva Investigational Site 10196

Waterbury, Connecticut, United States

Location

Teva Investigational Site 10191

Boynton Beach, Florida, United States

Location

Teva Investigational Site 11127

Brandon, Florida, United States

Location

Teva Investigational Site 11118

Clearwater, Florida, United States

Location

Teva Investigational Site 11141

Hialeah, Florida, United States

Location

Teva Investigational Site 11140

Kissimmee, Florida, United States

Location

Teva Investigational Site 10137

Miami, Florida, United States

Location

Teva Investigational Site 10153

Miami, Florida, United States

Location

Teva Investigational Site 11120

Miami, Florida, United States

Location

Teva Investigational Site 11128

Miami, Florida, United States

Location

Teva Investigational Site 11132

Miami, Florida, United States

Location

Teva Investigational Site 11145

Miami, Florida, United States

Location

Teva Investigational Site 10171

Ocala, Florida, United States

Location

Teva Investigational Site 10178

Sarasota, Florida, United States

Location

Teva Investigational Site 11103

South Miami, Florida, United States

Location

Teva Investigational Site 10161

Tallahassee, Florida, United States

Location

Teva Investigational Site 10139

Tampa, Florida, United States

Location

Teva Investigational Site 11114

Albany, Georgia, United States

Location

Teva Investigational Site 10111

Columbus, Georgia, United States

Location

Teva Investigational Site 11124

Columbus, Georgia, United States

Location

Teva Investigational Site 10180

Gainesville, Georgia, United States

Location

Teva Investigational Site 10168

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 11109

Idaho Falls, Idaho, United States

Location

Teva Investigational Site 10116

Meridian, Idaho, United States

Location

Teva Investigational Site 10127

South Bend, Indiana, United States

Location

Teva Investigational Site 10184

Iowa City, Iowa, United States

Location

Teva Investigational Site 10113

Metairie, Louisiana, United States

Location

Teva Investigational Site 10164

Bangor, Maine, United States

Location

Teva Investigational Site 10158

Bethesda, Maryland, United States

Location

Teva Investigational Site 10110

Largo, Maryland, United States

Location

Teva Investigational Site 10177

Wheaton, Maryland, United States

Location

Teva Investigational Site 10138

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10146

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10131

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10175

St Louis, Missouri, United States

Location

Teva Investigational Site 10189

St Louis, Missouri, United States

Location

Teva Investigational Site 11147

St Louis, Missouri, United States

Location

Teva Investigational Site 10118

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10150

Omaha, Nebraska, United States

Location

Teva Investigational Site 11144

Omaha, Nebraska, United States

Location

Teva Investigational Site 11136

Henderson, Nevada, United States

Location

Teva Investigational Site 10114

Brick, New Jersey, United States

Location

Teva Investigational Site 10193

Cherry Hill, New Jersey, United States

Location

Teva Investigational Site 10101

Hillsborough, New Jersey, United States

Location

Teva Investigational Site 10155

Skillman, New Jersey, United States

Location

Teva Investigational Site 10188

West Orange, New Jersey, United States

Location

Teva Investigational Site 11113

Albuquerque, New Mexico, United States

Location

Teva Investigational Site 10187

Brooklyn, New York, United States

Location

Teva Investigational Site 10120

New York, New York, United States

Location

Teva Investigational Site 10190

Newburgh, New York, United States

Location

Teva Investigational Site 10167

North Syracuse, New York, United States

Location

Teva Investigational Site 10112

Rochester, New York, United States

Location

Teva Investigational Site 10105

High Point, North Carolina, United States

Location

Teva Investigational Site 10122

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10194

Canton, Ohio, United States

Location

Teva Investigational Site 10107

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10123

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10144

Columbus, Ohio, United States

Location

Teva Investigational Site 11135

Dayton, Ohio, United States

Location

Teva Investigational Site 11115

Middleburg Heights, Ohio, United States

Location

Teva Investigational Site 10160

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10174

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10198

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 11108

Ashland, Oregon, United States

Location

Teva Investigational Site 10132

Eugene, Oregon, United States

Location

Teva Investigational Site 10135

Medford, Oregon, United States

Location

Teva Investigational Site 10142

Portland, Oregon, United States

Location

Teva Investigational Site 11104

Normal Square, Pennsylvania, United States

Location

Teva Investigational Site 10183

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 10166

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 10121

Upland, Pennsylvania, United States

Location

Teva Investigational Site 11119

East Providence, Rhode Island, United States

Location

Teva Investigational Site 10181

Lincoln, Rhode Island, United States

Location

Teva Investigational Site 10162

Providence, Rhode Island, United States

Location

Teva Investigational Site 10126

Charleston, South Carolina, United States

Location

Teva Investigational Site 10149

Charleston, South Carolina, United States

Location

Teva Investigational Site 10199

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 11131

Spartanburg, South Carolina, United States

Location

Teva Investigational Site 10119

Boerne, Texas, United States

Location

Teva Investigational Site 10141

Dallas, Texas, United States

Location

Teva Investigational Site 10192

Dallas, Texas, United States

Location

Teva Investigational Site 10148

El Paso, Texas, United States

Location

Teva Investigational Site 10115

San Antonio, Texas, United States

Location

Teva Investigational Site 11133

San Antonio, Texas, United States

Location

Teva Investigational Site 11134

San Antonio, Texas, United States

Location

Teva Investigational Site 10103

Waco, Texas, United States

Location

Teva Investigational Site 11143

Layton, Utah, United States

Location

Teva Investigational Site 10195

Provo, Utah, United States

Location

Teva Investigational Site 10134

South Burlington, Vermont, United States

Location

Teva Investigational Site 10159

Burke, Virginia, United States

Location

Teva Investigational Site 10102

Fairfax, Virginia, United States

Location

Teva Investigational Site 11105

Manassas, Virginia, United States

Location

Teva Investigational Site 10108

Richmond, Virginia, United States

Location

Teva Investigational Site 10124

Spokane, Washington, United States

Location

Teva Investigational Site 11117

Tacoma, Washington, United States

Location

Teva Investigational Site 11125

Tacoma, Washington, United States

Location

Teva Investigational Site 10170

Greenfield, Wisconsin, United States

Location

Teva Investigational Site 59107

Burgas, Bulgaria

Location

Teva Investigational Site 59103

Lovech, Bulgaria

Location

Teva Investigational Site 59106

Pleven, Bulgaria

Location

Teva Investigational Site 59104

Rousse, Bulgaria

Location

Teva Investigational Site 59101

Sofia, Bulgaria

Location

Teva Investigational Site 59102

Sofia, Bulgaria

Location

Teva Investigational Site 59105

Sofia, Bulgaria

Location

Teva Investigational Site 85105

Split, Croatia

Location

Teva Investigational Site 85102

Zagreb, Croatia

Location

Teva Investigational Site 85103

Zagreb, Croatia

Location

Teva Investigational Site 85104

Zagreb, Croatia

Location

Teva Investigational Site 36107

Balassagyarmat, Hungary

Location

Teva Investigational Site 36104

Budapest, Hungary

Location

Teva Investigational Site 36105

Budapest, Hungary

Location

Teva Investigational Site 36113

Csoma, Hungary

Location

Teva Investigational Site 36103

Miskolc, Hungary

Location

Teva Investigational Site 36108

Mosdós, Hungary

Location

Teva Investigational Site 36102

Nyíregyháza, Hungary

Location

Teva Investigational Site 36106

Szeged, Hungary

Location

Teva Investigational Site 36109

Szeged, Hungary

Location

Teva Investigational Site 36101

Szombathely, Hungary

Location

Teva Investigational Site 36111

Tatabánya, Hungary

Location

Teva Investigational Site 72111

Ashkelon, Israel

Location

Teva Investigational Site 72101

Haifa, Israel

Location

Teva Investigational Site 72102

Jerusalem, Israel

Location

Teva Investigational Site 72104

Jerusalem, Israel

Location

Teva Investigational Site 72109

Kfar Saba, Israel

Location

Teva Investigational Site 72106

Petah Tikva, Israel

Location

Teva Investigational Site 72107

Ramat Gan, Israel

Location

Teva Investigational Site 72103

Rehovot, Israel

Location

Teva Investigational Site 72108

Tel Aviv, Israel

Location

Teva Investigational Site 72110

Tel Aviv, Israel

Location

Teva Investigational Site 48107

Bialystok, Poland

Location

Teva Investigational Site 48105

Bydgoszcz, Poland

Location

Teva Investigational Site 48106

Grodzisk Mazowiecki, Poland

Location

Teva Investigational Site 48101

Lodz, Poland

Location

Teva Investigational Site 48108

Poznan, Poland

Location

Teva Investigational Site 48103

Tarnów, Poland

Location

Teva Investigational Site 48104

Wroclaw, Poland

Location

Teva Investigational Site 81101

Belgrade, Serbia

Location

Teva Investigational Site 81102

Belgrade, Serbia

Location

Teva Investigational Site 34101

Badalona, Spain

Location

Teva Investigational Site 34102

Barcelona, Spain

Location

Teva Investigational Site 34103

Salt, Spain

Location

Teva Investigational Site 80101

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 80113

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 80111

Donetsk, Ukraine

Location

Teva Investigational Site 80103

Kharkiv, Ukraine

Location

Teva Investigational Site 80117

Kharkiv, Ukraine

Location

Teva Investigational Site 80104

Kyiv, Ukraine

Location

Teva Investigational Site 80105

Kyiv, Ukraine

Location

Teva Investigational Site 80106

Kyiv, Ukraine

Location

Teva Investigational Site 80107

Kyiv, Ukraine

Location

Teva Investigational Site 80108

Kyiv, Ukraine

Location

Teva Investigational Site 80109

Kyiv, Ukraine

Location

Teva Investigational Site 80114

Odesa, Ukraine

Location

Teva Investigational Site 80118

Ternopil, Ukraine

Location

Teva Investigational Site 80112

Vinnytsia, Ukraine

Location

Teva Investigational Site 80115

Yalta, Ukraine

Location

Teva Investigational Site 80110

Zaporizhzhia, Ukraine

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

1-215-591-3000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 5, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-05

Locations

CR (4); SE (2); PL (7); BU (7); UA (16); HU (11); ES (3); US (129); IL (10)