I
`).
`
`l r
`
`Allergy and asthma proceedings : the offi(IM)
`v. 22, no. 6, suppl. 1 (Nov-Dec 2001)
`General Collection
`W1 AL5632L
`2001-12-19 ~
`
`:G9J@V
`CBlml~
`~~lr[}{] !N'lil~
`
`0 0
`
`Vol. 22, No. 6
`November-December 2001
`Supplement No. 1
`
`Patient Preference of Inhaled Nasal Corticosteroids
`
`S1
`
`Introduction: Patient preference of inhaled nasal corticosteroids
`William W. Storms, M.D.
`S5 Efficacy, safety, and patient preference of inhaled nasal corticosteroids: A review
`of pertinent published.data
`MichaelS. Blaiss, M.D.
`S11 Patient preferences and satisfaction with prescribed nasal steroids for allergic
`rhinitis
`Michael A. Kaliner, M.D.
`S17 Physician prescribing practices: The role of patient preference in the selection of
`nasal steroids
`Michael A. Kaliner, M.D.
`S23 Comparisons and contrasts: Patient and physician surveys
`Michael A. Kaliner, M.D.
`S27 Consensus and conclusions: Patient preference of inhaled nasal corticosteroids
`William W. Storms, M.D.
`
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`Allergy and Asthma Proceedings is the official journal of Regional, State and Local Allergy
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`

`Efficacy, Safety, and Patient
`Preference of Inhaled Nasal
`Corticosteroids: A Review of
`Pertinent Published Data 1
`
`-..;
`
`Michael S. 'Biaiss, M.D.
`
`ABSTRACT
`r-Atost clinical swdies of inhaled nasal corticosteroids have
`established comparable .w!f'ety and e.fficacy; therefore, there re(cid:173)
`mains little to distinguish the various products ji·m11 each other in
`the treatment (~f allergic rhinitis. However, patient preference is
`recog11ized increasint:IY as an importa11t .{i1ctor in selectir1g appro(cid:173)
`priate treatment. This review di.I'Cllsses the different methodologies
`thllt have been used to measure patient preference .for illffllllasal
`corticosteroids. Patient questionnaires and other instruments for
`assessment that are ltsed to IIU!asure such preferences are dis(cid:173)
`cussed as well as several d!fferellt study desig11s. Now, the clwl(cid:173)
`/enge is to implement more studies that show the reliability and
`consistency f!{ instruments used to asses.\' patiellf preference. f
`(Allergy and Asthma Proc 22:S5-S I 0, 200 I)
`--1
`
`Ph~si.ci~ns hav~ ~t ?hoice of s~veral i1~tranasal ~orti~o~t.e­
`JOJds to prescnbe for patients With allergrc rhuut1s.
`Although there have been countless contributions to the
`literature reviewing the safety and efficacy of these prod(cid:173)
`ucts, the issue of patient preference has been discussed
`relatively sparingly. As Taylor 1 concluded, in an article on
`understanding patients' choices, patient preferences are an
`integral part of the practice of medicine; therefore, because
`patients are becoming increasingly involved with their own
`health care, it has become more important to understand
`
`From the f!j_epartment nf Pediatrics and Medicine, Unil'ersily of
`lJ S FiJ
`Tennessee, Memphis, T"!_;
`Address correspondence and reprint requests to MichaelS. Blaiss,
`M.D., Asthma and Allergy Care, 300 Wabwt Bend Road, South,
`Cordova, 7N 38018
`
`how these preferences are generated and how they may
`influence a patient's effective participation in the health
`care decisions that are being made jointly with the physi(cid:173)
`cian.
`Most studies have indicated that there is little to distin(cid:173)
`guish the different commercially available intranasal ste(cid:173)
`roids regarding their safety and efficacy when they are used
`in their recommended dosages. However, physicians have
`noted that many times patients do have preferences and they
`often do not hesitate to express them. Most of the time, the
`reasons for these preferences are determined by a number of
`product attributes including its overall acceptability, deliv(cid:173)
`ery device, sensory attributes, and price. This article dis(cid:173)
`cusses some of the studies that have attempted to delineate
`the factors surrounding such patient preferences.
`
`COMPARATIVE EF'FICACY OF INHALED NASAL
`CORTICOSTEROIDS
`
`I n most ~tudies of intranasal steroid efficacy, a s~~ptom
`
`scale IS used to assess performance. In addJtJon, a
`quality-of-life tool is sometimes incorporated. Two recent
`clinical trials compared the efficacy of various intranasal
`corticosteroids in more than 900 patients. Mandl et a!. 2
`compared once-daily administration of mometasone furoate
`with lluticasone propionate for the treatment of perennial
`allergic rhinitis and Malone et a(1 compared fluticasone
`with triamcinolone acetonide aqueous in patients with sea(cid:173)
`sonal allergic rhinitis.
`The first study. a 12-wcek, randomized, double-blind,
`double-dummy parallel group study of 550 patients (aged
`12-77 years) with perennial allergic rhinitis,2 assessed ef(cid:173)
`ficacy using a 4-point scale (0 = absent to 3 = severe) for
`
`Allergy and Asthma Proc.
`
`85
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`

`rhinorrhea, congestion, sneezing, itching, burning, tearing,
`redness, and ear/palate itch. There were three treatment
`arms: (I) 200 11-g of mometasone furoate with tluticasone
`propionate placebo, (2) 200 11-g of tluticasone propionate
`with mometasone furoate placebo, and (3) mometasone
`furoate placebo with flutit:asone propionate placebo. Each
`was administered in a dosage of 2 sprays per nostril once
`daily in the morning. Both fluticasone and rnometasone
`caused significant reductions in mean daily reflective total
`nasal symptom score (TNSS; the sum of individual NSS,
`i.e., rhinorrhea, congestion, sneezing, and itch) as compared
`with placebo, with no significant differences between each
`other at any time period. Both active treatments also nu(cid:173)
`merically (but not statistically) reduced the nonnasal symp(cid:173)
`toms (i.e., itch/burning, teuling, redness, and ear/palate
`itch). Regarding safety, there were no differences in toler(cid:173)
`ability between treatment groups. The authors concluded
`that fluticasone and mometasone are equally efficacious und
`well tolerated in patients with perennial allergic rhinitis.
`In the second study, a multicenter, randomized, parallel(cid:173)
`group, single-blind study,3 352 patients with seasonal aller(cid:173)
`gic rhinitis were randomized to receive 2 sprays in each
`nostril of 220 11-g of triamcinolone acetonide aqueous or 200
`11-g of fluticasone propionate once daily in the morning for
`3 weeks. Efficacy was assessed using a similar 4-point scale
`(0 = absent to 3 = severe) for nasal discharge, nasal
`stuffiness, nasal itching, sneezing, ocular itchiness, tears,
`and redness. In addition, a Rhinoconjunctivitis Quality of
`Life Questionnaire (RQLQ)4 was used to assess patient
`quality of life at baseline and end of treatment. Adverse
`experiences were collected on diary curds at baseline and
`week 3. The results showed that fluticasone and triamcino(cid:173)
`lone both provided comparable improvement in total nasal
`and eye symptoms in patients with seasonal allergic rhinitis.
`Quality of life, as defined by the overall RQLQ, also was
`improved significantly by both treatments, with no signifi(cid:173)
`cant difference at the end of treatment. The occurrence of
`adverse events was similar in both groups.
`These two studies, which are just a sample of many in the
`literature, lead to the conclusion that differences in efficacy
`between the intranasal steroids are difficult to detect.
`
`COMPARATIVE SAFETY OF INHALED NASAL
`CORTICOSTEROIDS
`
`A similar picture is portrayed by reviewing the safety
`
`studies of modern intranasal steroids in the literature.
`For example, Wilson et a/. 5 examined the effects of various
`intranasal corticosteroids on adrenal, bone, and white blood
`cell markers in patients with allergic rhinitis. In a single(cid:173)
`blind, randomized, four-way crossover study of 20 patients,
`24-hour plasma cortisol and urine cortisol/creatinine mea(cid:173)
`surements were taken from serial blood and urine samples
`after 5 days of treatment at steady state with a 7-day
`washout interval. Three nasal corticosteroids (200 11-g of
`budesonide, 200 11-g of mometasone furoate, and 220 11-g of
`
`triamcinolone acetonide aqueous) and placebo were admin(cid:173)
`istered once daily. There was no significant difference be(cid:173)
`tween placebo and the active treatments in any of the
`markers of adrenal suppression; the diurnal circadian
`rhythm was unaffected and there were only a few patients
`with abnormally low cortisol values. Regarding the bone
`and white blood cell markers, the active treatments pro(cid:173)
`duced no significant suppression of osteocalcin or the blood
`eosinophil count compared with placebo. These results re(cid:173)
`flected the good safety profile of these aqueous intranasal
`corticosteroid preparations when they are used at clinically
`recommended dosages.
`In another study, Skoner et al.C' evuluated the effect of
`triamcinolone acetonide aqueous and fluticasone propionate
`nasal sprays on hypothalamic-pituitary-adrenal (HPA) axis
`function and short-term growth in 59 4- to 10-year-old
`children with allergic rhinitis. In this double- or single(cid:173)
`blind, placebo-controlled, four-way crossover study, pa(cid:173)
`tients were randomized to receive II 0 J.Lg of triamcinolone
`(2 sprays), 220 J.Lg of triamcinolone (4 sprays), 200 J.Lg of
`fluticasonc (4 sprays), or placebo (2 or 4 sprays). After a
`2-wcek baseline period, patients were evaluated weekly for
`four 2-week treatment periods (and three 2-week intervals
`between treatment periods). There were no clinically sig(cid:173)
`nificant short-term effects on linear lower-leg growth rate
`after either once-daily triamcinolone or fluticasone when
`administered at recommended doses. One hundred ten or
`220 11-g of triamcinolone once daily did not suppress HPA
`axis function; however, 200 11-g of fluticasone once daily for
`the same duration significantly suppressed HPA axis func(cid:173)
`tion. These results suggest there may be important differ(cid:173)
`ences in adrenal effects among intranasal corticosteroids.
`In a long-term growth study, Agertoft and Pederson7
`examined the effect of inhaled budesonide on adult height in
`children with asthma. This prospective studied reported on
`21 I children who attained adult height: 142 budesonide(cid:173)
`treated children with asthma, 18 control patients with
`asthma who never received inhaled corticosteroids, and 51
`healthy siblings of patients in the budesonide group who
`also served as controls.
`The I 0-year growth data for children who reached adult
`height showed that although budesonide was associated
`with a significant change in growth rate during the first
`years of treatment, as compared with the run-in period, the
`adult height was not affected adversely. The initial growth
`retardation was significantly correlated with age (p = 0.04),
`with a more pronounced reduction in younger children.
`Furthermore, the budesonide-treated children, 40 of whom
`also used intranasal steroids for an average of 24 months,
`reached their targeted adult height to the same extent as
`their healthy siblings and the children in the control group. 7
`These studies did not include instruments to assess pa(cid:173)
`tient preferences. However, patient preference tools could
`become a routine part of these types of clinical studies.
`
`86
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`COMPARATIVE DATA ON PATIENT
`PREFERENCE OF INHALED NASAL
`CORTICOSTEROIDS
`
`A review of .t?e literature reveals. several st~1d~es that
`
`more specifically analyzed the d1fferences m mtrana(cid:173)
`sal corticosteroids with respect to patient preference. In the
`first study, Adamopoulos et a!. 8 compared the efficacy and
`acceptability of budesonide (200 p.,g twice daily [b.i.d.]) and
`beclomethasone dipropionate (1 00 p.g four times daily
`[q.i.d.l) in adults with perennial allergic rhinitis. This clin(cid:173)
`ical trial used an open, randomized, crossover design. There
`were 6 weeks of treatment with each dmg, with patient
`visits every 3 weeks. Scores for blocked nose, runny nose,
`sneezing, and eye symptoms were recorded on daily diary
`cards. Efficacy was assessed using a 0-3 scale in which 0 =
`no symptoms and 3 = severe symptoms (i.e., sufficiently
`troublesome to interfere with normal daily activity or night(cid:173)
`time sleep). With regard to the efficacy results, the mean
`TNSS was significantly (p = 0.00 I) lower with budesonide
`than with beclomethasone. Also, there were significantly
`fewer reports of blocked nose (p = 0.004 ), runny nose (p =
`().()005), and sore eyes (p = 0.047) during budesonide
`treatment as compared with beclomethasone treatment.
`A fairly simple assessment of patient preference was
`performed also; preference for "effects," "side effects," and
`"overall" was stated by the patient at the end of the study.
`A significantly greater proportion of patients stated a pref(cid:173)
`erence for budesonide over beclomethasone based on effect
`(p = 0.000 I), side effects (p = 0.0 I), and overall (p =
`0.000 I). The instrument used here to address patient pref(cid:173)
`erence is perhaps one of the first seen . It shows that assess(cid:173)
`ment of preference can be built into what is essentially a
`traditional comparative trial of safety and efficacy.
`Grubbe et alY performed a study in patients with peren(cid:173)
`nial allergic rhinitis in which intranasal therapy with triam(cid:173)
`cinolone acctonide aerosol (220 p.g once daily) was com(cid:173)
`pared with beclomethasone dipropionate (168 p.g b.i.d.).
`This study was especially interesting in that it compared
`patient preferences for an aerosol preparation (triamcino(cid:173)
`lone) versus an aqueous preparation (beclomcthasone). The
`4-week, single-blind, randomized, controlled, multicenter,
`parallel-group trial was designed to compare the efficacy,
`tolerability, and specific treatment-related side effects in
`313 patients. Patients recorded symptoms (rhinorrhea, nasal
`congestion, sneezing, nasal itching, and postnasal drip) in
`daily diaries. Symptom reduction also was assessed by
`physicians on a 5-point scale (0 = no relief to 4 = complete
`relief) every 2 weeks. To assess specific treatment-related
`side effects from the study medications, patients completed
`a daily questionnaire in which they recorded the occmrence
`of I 0 specific complaints known to be associated with
`intranasal steroids (Table 1). If patients responded with a
`"yes" to a complaint, they rated the annoyance of that
`complaint on a scale of 0-5. The results of this trial indi(cid:173)
`cated that triamcinolone acetonide aerosol is comparable
`
`TABLE I
`Daily Patient Questionnaire on Treatment-Related
`Side Effects9
`I . Some of the medicine ran down my throat
`2. Some of the medicine ran out my nose
`3. The medicine tasted bad, left a bad taste
`4. It made me sneeze
`5. It made my throat sore
`6. It made my nose sting and/or burn
`7. It made my nose bleed
`8. It dried the inside of my nostrils
`9. There was blood in my nasal mucus when I blew my
`nose
`10. It made my nose feel stuffed up
`Response was either yes or no. If yes, then attribute.\· were
`mted on a scale (if' 0-5.
`
`with beclomethasone dipropionate in relieving the nasal
`symptoms of perennial allergic rhinitis. Both treatments
`were well tolerated, although specific treatment-related
`events occurred significantly more frequently and were sig(cid:173)
`nificantly more severe with beclomethasone. Occurrence of
`medication nm-off was less with triamcinolone than with
`beclomethasone (p = 0.001 ); severity of medication run-off
`also was less with triamcinolone (p = 0.0024). Bad taste
`was more severe in the patients who received beclometha(cid:173)
`sone (p = 0.0024 ).
`An even more sophisticated assessment of patient pref(cid:173)
`erences for intranasal steroids was undertaken in a study by
`Gerson et a/., 10 who determined the preference of adults
`with allergic rhinitis for triamcinolone acetonide aqueous.
`fluticasone propionate, or beclomethasone dipropionate
`based on sensory perceptions and acceptability. In this dou(cid:173)
`ble-blind crossover study of 94 patients, preference was
`assessed using a 13-point questionnaire, which was admin(cid:173)
`istered by a blinded third-party interviewer after each drug
`treatment. The actual treatment procedure consisted of 2
`sprays/nostril, in random order, of each study drug. Before
`each treutment, putients neutralized the senses by chewing
`unsalted crackers, rinsing the mouth with room temperature
`water, and sniffing a swatch of wool cloth. Treatments
`occurred at 30-minute intervals. Immediately after each
`treatment, 1 0 items from the questionnaire were asked by
`the interviewer; 2 minutes after each treatment, the three
`remaining items were asked (Table II).
`The order of drug administration did not affect mean
`ratings for each product. However, "initial irritation" scores
`were significantly higher when treatments were adminis(cid:173)
`the order of lluticasone-triamcinolone-beclo(cid:173)
`tered in
`methasone. and "liking of taste" scores were significantly
`lower when treatments were administered in the order of
`beclomethasone-t1uticasone-triamcinolone.
`The patient preference instrument in this study used a
`I 00-point scale to assess each attribute, which should enable
`
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`TABLE II
`
`Nasal Spray Evaluation Questionnairc 10
`
`Item
`
`Score = 0
`
`Score = 100
`
`Scale
`
`hnmediately after Administration
`Overall comfort
`Run-off
`Irritation
`Urge to sneeze
`Odor strength
`Liking of odor
`Taste strength
`Bitter taste
`Liking of taste
`Moist sensation
`
`2 Minutes after Administration
`Run-off
`Irritation
`Overall liking of product
`
`Not at all comfortable
`None at all
`None at all
`No urge at all
`No odor at all
`Dislike an extreme amount
`No taste at all
`Not at all bitter
`Dislike an extreme arnount
`Extremely dry
`
`Extremely comfortable
`An extreme amount
`An extreme amount
`Extremely strong urge
`Extremely strong odor
`Like an extreme amount
`Extremely strong taste
`Extremely bitter
`Like an extreme amount
`Extremely moist
`
`None at all
`None at all
`Dislike an extreme amount
`
`An extreme amount
`An extreme amount
`Like an extreme amount
`
`a more sensitive assessment of product differences. There
`was a significant preference for triamcinolone over rlutica(cid:173)
`sone for "liking of odor," "liking of taste," ''odor strength,"
`and "overall liking of product." Pati~nts also significantly
`preferred triamcinolone over beclomethasone for ''liking of
`odor," "moist sensation," and "odor str~ngth" (Figs. I and 2).
`This study shows that patients are able to distinguish one
`medication from another. In addition, performing an assess(cid:173)
`ment both immediately after administration as well as 2
`
`minutes thereafter offers a more realistic ~valuation of a
`patient's pref~rence because it mor~ accurately follows for(cid:173)
`mation of pr~ference in real life.
`This instrument for assessing pali~ nt preference was
`adapted and then used in a study by Bachert et a/. 11 They
`assessed the same 10 ite ms as Gerson ef a/. 10 immediately
`after administration of each product; however, they in(cid:173)
`cluded an additional item (strength of aftertaste) for assess(cid:173)
`ment 2 minutes after administration.
`
`0
`
`20
`
`Mean score
`40
`60
`
`80
`
`100
`
`Overall comfort
`
`Irritation
`
`Urge to snlot:ZC
`
`• triamcinolone
`acetonide aqueous
`
`Elfluticasone
`propionate
`
`Odor strength
`
`D beclom ethasone
`
`Likinj.\ of odor ~~~~··~~·~·"~,,.~,~-"~'"~,~~·,~···!· .... •***L-__ w_p_ro_p_i_on_a_t_e __ ~
`
`Taste strength
`
`Bitter taste
`
`Triamcinolone is significantly better than beclomethasone: •p :"' .01, ••p :"' .001.
`Triamcinolone is significantly better than fluticasone; t P :S .04, +p ~ .001.
`
`Fif{ure I. Uesu/1.1· irllllledialely afier admillistrmion. '"
`
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`

`Mean score
`40
`60
`
`o
`
`20
`
`so
`
`too
`
`Run-off
`
`..c Irritation
`
`"' Q) =
`·;::: -<
`
`Overall
`liking of
`product
`
`• triamcinolone
`acetonide aqueous
`
`IEl tluticasone
`propionate
`
`D bed om ethason e
`dipropionate
`
`*
`
`Triamcinolone is significantly better than FP; •p <: .OS.
`Figure 2. Rt'.mifs 2 lllimrte.\· afier adnrinistratioJI (N = 94). 1"
`
`In this double-blind crossover study with 95 patients.
`triamcinolone aceton ide aqueous (55 J,Lg/spray ). flut icasone
`propionate 150 J,Lg/spray). and monH.:tasone furnate 150 f.Lg/
`spray) were compared for patient preference in adults with
`allergic rhinitis. Within 7 days of a screening visit, prefer(cid:173)
`ence was assessed with the Nasal Spray Evaluation Ques(cid:173)
`tionnaire administered by a blinded third-party interviewer
`after treatment. The three treatments 12 sprays/nostril daily)
`were administered in random order at 30-minute intervals.
`As with the previous study design, patients neutralized their
`senses (with unsalted crackers. mouth rinse. and swatch of
`wool cloth) before each treatment.
`Immediately aFter administration. patients showed a sig(cid:173)
`nificant prcl'erem:e for triamcinolone over lluticasone for
`
`TABLE III
`
`Ovendl Nasal Spray Questionnaire ''
`
`I. Rank your preference for the prescription of each nasal
`-;pray as I (preferred to be most prescribed ) to 3
`(preferred to be least prescribed)
`1. Evaluate your expected compliance for each nasal
`spray on a scale of I (definitely comply with the
`prescription) to 4 (definitely not comply with the
`prescription)
`
`liking of odor, odor strength, moist sen-;ation, and strength
`of aftertaste and 2 minutes after administration, they signif(cid:173)
`icantly preferred it for strength of aftertaste. amount of
`irritation, and overall liking of the product. Patients signif(cid:173)
`icantly rated triamcinolone over mometusonc for overall
`comfol'l. odor strength. liking of odor. taste strength. liking
`of taste. moist sensation. and irritation immediately after
`admini-;tration and for strength of aftertaste. amount of
`irritation. and overall liking of the product 2 minutes after
`administration IFigs. J and 4).
`This study also addressed the issue of compliance and
`preference by including two additional questions to the pa(cid:173)
`tients, which they answered after all three treatments had been
`administered (Table III). Overall, 54.79'r- of patients would
`prefer to be prescribed triamcinolone as opposed to those who
`would prefer lluticasone (21 . I %) and mometasone ( 14.11Jf<
`p = ().()()I ). The nu~ority of patients ( 6 7.4%) responded that
`they definitely would comply with triamcinolone therapy com(cid:173)
`pared with 54.7% who responded that they would comply with
`tluticusone and 49.)l~, who would comply with mometasone.
`
`Mean score
`10 20 30 40 50 60 70 80 90 100
`
`0
`
`1~~~~~~~~~~~-:*:*.;-~~~~
`Overall comfort
`···· '···" '·"···· .,.
`Run-off ~~~~r· * t
`Irritation .........
`Urge to sneeze ~ ........... ;
`
`·.-·.·-~-· .. •
`
`Odor strength
`
`- - - - - ,
`• triamcinolone
`acetonide aqueous
`
`El tluticasone
`propionate
`
`D mometasone ruroate
`
`~~~··•:!:
`Liking of odor ~
`-
`***t
`
`Taste strength
`
`Bitter taste ~
`
`TAA is significantly better than MF; •p :0:: .05, .. p :0:: .01, ... p <: .001.
`TAAissignificantlybetterthanFP; 1P <: .05, 11P <: .01, 'p 5 .001.
`Figure 3. l~nu/ts inrmedilllel\' tl(ier trtlministrotion (N = 95). intent 111 lrl't/1. 1 1
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`0
`
`lO
`
`20
`
`30
`
`Mean score
`40
`60
`50
`
`70
`
`!10
`
`90
`
`100
`
`Strength of
`aftertaste
`
`Run-off
`
`Irritation
`
`Overall liking of
`product
`
`• triamcinolone
`acetonide aqueous
`0 tluticasone
`propionate
`Dmometasone
`furoate
`
`** t
`
`TAA is significantly better than MF; •p '!E 0.01, •·p~ 0.001 .
`TAA is significantly better than FP: 1 P'!!: 0.05. t p '!!: 0.01 .
`Figure 4. Results 2 minu/es afier administmtion (N
`
`95 ). intent to lrel/1 . 11
`
`PATIENT PREFERENCI~ QUESTIONNAIRES AND
`INSTRUMENTS: CONCLUSIONS
`
`Based on the data discussed in this review, it can be
`
`concluded that published data on patient preference
`f<H intranasal steroids tend to support our experience in
`practice. In the studies reviewed, patients were able to
`di scriminate among intranasal corticosteroids based on each
`product's sensory attributes. However, it is dear that no
`standard patient preference questionnaire is available at this
`time. In fact, the re is only one patient preference question(cid:173)
`naire that has been used in more than one study in the same
`format. 111•11 Now, the challenge is to develop a reliable,
`consistent instrument and method of assessment for these
`patie nt preference studies, which will allow us to include
`patient preference as a standard assessment tool in all of our
`intranasal steroid clinical studies. Some of the questions yet
`to be explored further are <IS follows:
`
`• Method of assessment-
`can this be accomplished ade(cid:173)
`quatel y by the patient or should it be administered by a
`third party?
`• Rating scale-should the optimum range be 0-4,0-100,
`or something else?
`• Study design-is a crossover design better than a parallel
`group'? What should the duration of drug therapy he ii.e ..
`is a single-dose study superior to one that examines the
`effects of chronic treatment)? Also, is an immediate
`assessment more important than a 2-minute assessment
`(or vice Fe rsa'!)
`• What is the optimum patient sample size?
`• When can differences in the results be recognized as
`being clinically significant?
`
`Meanwhile, as these questions are being addressed in clin(cid:173)
`ical studies. we as physicians can incorporate patient prefer(cid:173)
`ence imo everyday interaction with patients in our practices.
`
`REFERENCES
`
`4.
`
`I. Taylor TR. Understanding the clwices that patients make . .1 A nl
`lloartl I 'am Pral:t 13: 124- LB. 2000.
`2. Mandl M, Nolnp K. Lutsky BN, et al. Comparison of once daily
`tnomctasnne fumatc tNusnncx) and rluticasone propionHtc aqueous
`nasal sprays for the treatment or percrmiul t·hinitis. Ann Allergy
`Acahma lm1mnml 7lJ:370-:l45. llJ<J7.
`:1. Malone D. Lim.IC. Townsend L. ct al. Comp:trison <lf sal'dy, crticacy
`:md cost or ITiamcinolonc <lcclonidc anti lhnicasone prnpionat ~ nasal
`sprays in patients wilh seasonal allcrgiL: rhinitis . .I Allergy ('lin
`lmmutml IO.'i :S:l\10. 2000 CAhs ll:lX).
`Juniper EF, ;llld Guyatt GH. Development anti testing or a ne w
`measure or health slatus for clinical tri;tl s in rhinoconjunctivitis. Clin
`bp Allergy 21 :77- lD. I<JlJ I.
`5. Wilson AM. Sims U. McFarlane LC, cl al. EITccls of inl ranasal mrti(cid:173)
`cosJCroids on adrenal, bone. and hlood markers of syslelllil: aclivity in
`allergic rhinitis. 1 Allergy Clin lnumrnol 102:.'i'JX --W4. 19'JX.
`C1. Skoncr DP. Angclini Bl .. (icmilc DA. ct al . Comparison or 1hc l'ITccts
`of intranasal triamdnolone Hcdonide and l'lut iGl S O ih; prupiu11atc on
`HPA axis "nd shorHerm growth in children with :lllcrgic rhiniti s . .I
`Allergy Clin lnnnunol I 07:506. 20tll.
`7. Agcrtol't L. and Pedersen S. Effect of long-term trcatmctll with
`inhaled budcsonidc on adult height in childre n with aslhnw. N t:ngl
`J Mcd J4:1: IOM - 106<J, 2000.
`X. Adanl \lpllUios G. Manolopoulos L. and Giolakis I. A comparis<lll of
`the efficacy and paticnl acccptahility or hllllcsonidc and bcdonK'Iha (cid:173)
`sonc dipropinnalc aqu eous nasal sprays in paticms with perennial
`rhiniti s. Clin Otolaryngul 20:340-34·1, llJ<J.'i.
`(irubhc K, Alklglass JM. Casale TB . ct al. lntr:masal lh.:rapy
`with once-daily triam ci nolone acctonid~ aerusol versus twice(cid:173)
`daily beclomcthason<! dipmpionah: aqueou s spray in patients with
`p.:n:nnial allergic rhiniti s. CurT Thcr Res ('lin Exp ~7:X2.'i -· X:1 :-;.
`llJ%.
`I 0. Gerson I, Green I., and Fish ken D. l'aticnl prel'crenee and scn-;my
`comparison s or nasal spray allergy medications. J Sensory Stud it''
`4:491 - 4%. llJIJ<.J.
`II . Bachc:rt C. Ciuntnwski P. Nerhcinr 0 , ct al. Pat ient pn:ll:rc'llL'L' and
`sensory comparisons or lhrcc nasal steroids : lriamcinolonc ac c·tonide
`aqueous nasal spt·ay. fluticasonc propionate and mometasonc ruroaiL'.
`! I
`Allergy .'i.'i(suppl 6:1): 197. 2000.
`
`<.J .
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`810
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