efficacy PROFILE

effective asthma control

Significant improvements in lung function, an early onset of action, and
sustained efficacy in a clinical trials program1

Trial 1: Mean change from baseline in trough FEV1 at each visit by treatment group (FAS)1

AirDuo RespiClick Trial 1 efficacy graph
Trial 1: Study Design
 
Trial 1 STUDY Design:

This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared AirDuo RespiClick 55/14 mcg and 113/14 mcg (1 inhalation BID) and placebo in adolescent and adult patients with persistent symptomatic asthma despite low-dose or mid-dose ICS or ICS/LABA therapy. Additional arms in this study received ArmonAir RespiClick® (fluticasone propionate) Inhalation Powder 55 mcg and 113 mcg (1 inhalation BID).1

Trial 2: Mean change from baseline in trough FEV1 at each visit by treatment group (FAS)1

AirDuo RespiClick Trial 2 efficacy graph
Trial 2: Study Design
 
Trial 2 STUDY Design:

This randomized, double-blind, placebo-controlled, 12-week, global efficacy and safety trial compared AirDuo RespiClick 113/14 mcg and 232/14 mcg (1 inhalation BID) and placebo in adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy. Additional arms in this study received ArmonAir RespiClick (fluticasone propionate) Inhalation Powder 113 mcg and 232 mcg (1 inhalation BID).1

FEV1=forced expiratory volume in 1 second.

FAS=full analysis set.

Trial 1: Serial spirometry—Mean change from baseline in FEV1 (L) at Day 1 by time point and treatment group (FAS; serial spirometry subset)1

AirDuo RespiClick Trial 1 Serial spirometry graph
Primary Endpoints
 
PRIMARY ENDPOINTS IN TRIAL STUDies 1 and 2:

The primary endpoints for these trials were the changes from baseline in trough FEV1 at Week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at Week 12 analyzed for a subset of 312 patients who performed postdose serial spirometry.1

AUEC0-12h=area under effect-time curve 0-12 hours.

Trial 2: Serial spirometry—Mean change from baseline in FEV1 (L) at Day 1 by time point and treatment group  (FAS; serial spirometry subset)1

AirDuo RespiClick Trial 2 Serial spirometry graph
Primary Endpoints
 
PRIMARY ENDPOINTS IN TRIAL STUDies 1 and 2:

The primary endpoints for these trials were the changes from baseline in trough FEV1 at Week 12 for all patients and standardized baseline-adjusted FEV1 AUEC0-12h at Week 12 analyzed for a subset of 312 patients who performed postdose serial spirometry.1

AUEC0-12h=area under effect-time curve 0-12 hours.

safety PROFILE

established safety profile

The safety of AirDuo RespiClick was evaluated
in patients with asthma who were previously treated with an ICS1

  • In a long-term safety study, the types of adverse reactions were similar to those reported in placebo-controlled studies1
AirDuo adverse reaction chart

*Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungal.

Important Safety Information for AirDuo RespiClick/Authorized Generic

Contraindications: AirDuo RespiClick is contraindicated in:

  • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
  • Patients with known severe hypersensitivity to milk proteins or any ingredients of AirDuo RespiClick

Serious Asthma-Related Events—Hospitalizations, Intubations, Death: Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death. Available data from controlled clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with ICS, data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone

Deterioration of Disease and Acute Episodes: AirDuo RespiClick should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. AirDuo RespiClick is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not AirDuo RespiClick, should be used to relieve acute symptoms such as shortness of breath

Excessive Use and Use with Other Long acting Beta2-Agonists: AirDuo RespiClick should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo RespiClick should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason

Local Effects of ICS: Oropharyngeal candidiasis has occurred in patients treated with AirDuo RespiClick. Advise patients to rinse the mouth with water without swallowing following inhalation

Immunosuppression: Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections

Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. Taper patients slowly from systemic corticosteroids if transferring to AirDuo RespiClick

Hypercorticism and Adrenal Suppression may occur with high doses of ICS, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue AirDuo RespiClick slowly

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with AirDuo RespiClick is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur

Paradoxical Bronchospasm and Upper Airway Symptoms: If paradoxical bronchospasm occurs, discontinue AirDuo RespiClick immediately and institute alternative therapy

Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of AirDuo RespiClick. Discontinue AirDuo RespiClick if such reactions occur

Cardiovascular and Central Nervous System Effects: Salmeterol, a component of AirDuo RespiClick, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. If such effects occur, AirDuo RespiClick may need to be discontinued. AirDuo RespiClick should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension

Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care

Effect on Growth: ICS, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients

Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate, a component of AirDuo RespiClick, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered

Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy

Coexisting Conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines

Hypokalemia and Hyperglycemia: Be alert to hypokalemia and hyperglycemia

Adverse Reactions: Most common adverse reactions (≥3%) in patients taking AirDuo RespiClick 55/14 mcg twice daily, 113/14 mcg twice daily, 232/14 mcg twice daily, and placebo, respectively, were nasopharyngitis (8.6%, 4.8%, 6.9%, 4.4%), oral candidiasis (1.6%, 2.2%, 3.4%, 0.7%), back pain (3.1%, 0.7%, 0%, 1.8%), headache (5.5%, 4.8%, 2.8%, 4.4%), and cough (2.3%, 3.7%, 0.7%, 2.6%)

Reference: 1. AirDuo RespiClick Prescribing Information. Frazer, PA: Teva Respiratory, LLC.