Clinical trial NCT02157935: Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease
Official title: A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® Pressurized Metered-Dose Inhaler (pMDI) 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in Cronic Obstructive Pulmonary Disease (COPD) Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD Patients
Keywords: COPD, turbuhaler, pMDI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 2026
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the efficacy of Symbicort® pMDI and Formoterol Turbuhaler in reducing exacerbations in patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description: A Phase IIIB, 6-Month, Double-blind, Double-dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of Symbicort® pMDI 160/4.5 μg x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 μg x 2 Inhalations Twice-daily in COPD Patients.

Eligibility criteria: Inclusion Criteria:

3. A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the GOLD guidelines.

4. Current or previous smoker with a smoking history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for 1 year).

5. Post-bronchodilator FEV1/forced vital capacity (FVC) \<0.7 (70%) and FEV1 ≤70% of predicted normal (PN) value.

6. Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months prior to study start.

7. A score of ≥2 on the modified medical research council (MMRC) dyspnea scale. 8. Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, IM, IV) corticosteroids (a minimum 3 day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or \>24 hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2-52 weeks before Visit 1 (i.e., not within the 14 days prior to Visit 1). A history of an exacerbation treated exclusively with antibiotics will not be considered adequate.

Exclusion Criteria:

1. A history of asthma at or after 18 years of age.
2. Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure (including significant cor pulmonale), uncontrolled hypertension as defined by the Investigator, or any other relevant cardiovascular disorder as judged by the Investigator.
3. Known homozygous alpha-1 antitrypsin deficiency.
4. Any significant disease or disorder (e.g., gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study.
5. A history of malignancy (except basal cell carcinoma) within the past 5 years.
6. Active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases.
7. Subjects who have needed additions or alterations to their usual maintenance or change in formulation of rescue therapy for COPD due to worsening symptoms within the 14 days prior to Visit 1 and up to Visit 3.
8. CXR (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment, or put the subject at risk because of participation in the study.
9. Risk factors for pneumonia: immune suppression (HIV, lupus) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's disease, myasthenia gravis, etc.).
10. Pneumonia not resolved within 14 days of Visit 1.
11. Moderate or severe COPD exacerbation that has not resolved within 14 days prior to Visit 1 or a moderate or severe COPD exacerbation that occurs between Visit 1 and Visit 2.
12. Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
13. Subjects who are currently in the intensive rehabilitation phase or scheduled to begin new participation (intensive rehabilitation phase) in a pulmonary rehabilitation program during the study or have started a new pulmonary rehabilitation program within 60 days of Visit 1. Subjects in the maintenance phase of pulmonary rehabilitation program are not excluded.
14. Treatment with oral, parenteral, or intra-articular corticosteroids within 4 weeks prior to Visit 1.
15. Omalizumab or any other monoclonal or polyclonal antibody therapy taken for any reason within 6 months prior to Visit 1.

Primary outcomes:
measure: The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days
timeFrame: Randomization at Week 0 to End of Treatment (EoT) W 26
Secondary outcomes:
measure: Number of Patients With Moderate or Severe COPD Exacerbation.
timeFrame: From randomzation to EoT W 26
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: From Run-in W -4 to EoT W 26
measure: Pre-dose/Pre-bronchodilator FEV1 at the Study Site
timeFrame: From Run-in W -4 to EoT W 26
measure: Total Rescue Medication Use (Average Puffs/Day)
timeFrame: From Run-in W -4 to EoT W 26
measure: Nights With Awakening Due to COPD
timeFrame: From Run-in W -4 to EoT W 26
Other outcomes:
Locations:
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country: Bulgaria
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country: Chile
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country: Chile
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country: Czechia
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city: Praha 6
country: Czechia
facility: Research Site
city: Praha 6
country: Czechia
facility: Research Site
city: Strakonice
country: Czechia
facility: Research Site
city: Strakonice
country: Czechia
facility: Research Site
city: Zatec
country: Czechia
facility: Research Site
city: Zatec
country: Czechia
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Bad Lippspringe
country: Germany
facility: Research Site
city: Bad Lippspringe
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Koblenz
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: San Juan del Rio
country: Mexico
facility: Research Site
city: San Juan del Rio
country: Mexico
facility: Research Site
city: Sonora
country: Mexico
facility: Research Site
city: Sonora
country: Mexico
facility: Research Site
city: Aleksandrów Łódzki
country: Poland
facility: Research Site
city: Aleksandrów Łódzki
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bielsk Podlaski
country: Poland
facility: Research Site
city: Bielsk Podlaski
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Kościan
country: Poland
facility: Research Site
city: Kościan
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Pila
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Skarżysko-Kamienna
country: Poland
facility: Research Site
city: Skarżysko-Kamienna
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Żnin
country: Poland
facility: Research Site
city: Żnin
country: Poland
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Amanzimtoti
country: South Africa
facility: Research Site
city: Amanzimtoti
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Badalona(Barcelona)
country: Spain
facility: Research Site
city: Badalona(Barcelona)
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Loja (Granada)
country: Spain
facility: Research Site
city: Loja (Granada)
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
affiliation: Pulmonary Research Insititute of Southeast Michigan
name: Gary T Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References: