CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). Read MoreSafety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV₁ <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

AIR-CF1: Study Design

THE EFFICACY AND SAFETY OF CAYSTON HAS BEEN ESTABLISHED THROUGH MULTIPLE TRIALS^1-3

AIR-CF1¹

AIR-CF1 (pivotal study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of CAYSTON.

n = 80 TID
One 28-day course of CAYSTON therapy
Study length: 1.5 months

AIR-CF2²

AIR-CF2 was a randomized, double-blind, placebo-controlled trial that contributed to the safety and microbiology profile of CAYSTON.

n = 135 (69 BID, 66 TID)
One 28-day course of CAYSTON therapy, after 1 course of tobramycin nebulizer solution (TNS)
Study length: 4 months

AIR-CF3³

AIR-CF3 was an open-label follow-on trial that assessed the safety and microbiology profile of CAYSTON.

n = 274 (85 BID, 189 TID)
Up to nine 28-day courses of CAYSTON
Study length: 18 months

The AIR-CF1 Study Was the Pivotal Trial That Evaluated the Efficacy and Safety Profile of CAYSTON

AIR-CF1: Study Design

Study Description

AIR-CF1 was a Phase 3, double-blind, multicenter, international, randomized, placebo-controlled trial of 164 patients (≥7 years old with FEV₁ of 25%-75% predicted) with CF and Pa to evaluate CAYSTON over a period of 28 days of treatment

Treatment

Patients were randomized to receive 28 days of treatment with CAYSTON 75 mg or placebo 3 times a day*
All patients were required to take a dose of an inhaled bronchodilator (beta-agonist) prior to taking a dose of CAYSTON or placebo
Patients received CAYSTON or placebo administered with the ALTERA^® Nebulizer System

Endpoints

Primary endpoint was improvement in respiratory symptoms on the last day of treatment, as measured by the Respiratory Symptoms Scale of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).¹ Respiratory symptoms were also assessed 2 weeks after completion of treatment
Secondary endpoint was the mean relative change in FEV₁ (L)¹

Treatment Experience

Patients were required to have been off antibiotics for at least 28 days before treatment with study drug
Patients were receiving standard care for CF, including drugs for obstructive airway diseases

*1 course = 28 days of treatment.

AIR-CF1: baseline characteristics¹

Learn About AIR-CF1 Study Efficacy Results

Tap for Important Safety Information

CAYSTON is contraindicated in patients with a known allergy to aztreonam.

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Please read the following Important Safety Information before your video begins.

Important Safety Information and Indication

Contraindications

CAYSTON is contraindicated in patients with a known allergy to aztreonam.

INDICATION

CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV₁ <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pa in the lungs.

Warnings and Precautions

Allergic Reactions: Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with CAYSTON in clinical trials. If an allergic reaction occurs, stop administration of CAYSTON and initiate treatment as appropriate. Caution is advised when administering CAYSTON to patients if they have a history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, since cross-reactivity may occur.
Bronchospasm: Bronchospasm is a complication associated with nebulized therapies, including CAYSTON. Reduction of 15% or more in forced expiratory volume in 1 second (FEV₁) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with CAYSTON.
Decreases in FEV₁ After 28-Day Treatment Cycle: In clinical trials, patients with increases in FEV₁ during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV₁ declined after the treatment period. Healthcare providers should consider a patient’s baseline FEV₁ measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV₁ are caused by a pulmonary exacerbation.
Development of Drug-Resistant Bacteria: Prescribing CAYSTON in the absence of known Pa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

Adverse reactions (>5%) in CAYSTON patients were cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, and vomiting. Adverse reactions reported (<5%) in CAYSTON patients were bronchospasm and rash.

Indication

Please click here to see full Prescribing Information.

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